Solaray L Lysine with Beta Glucan by Nutraceutical Corp.

LIKELY EFFECTIVE

• Coronary heart disease (CHD). Consuming products containing at least 3.6 grams of soluble fiber, including beta-glucans, per day may reduce the risk of CHD when consumed as part of a diet low in saturated fat and cholesterol. Details: Clinical research shows that a diet containing foods high in beta-glucans, such as oats and barley, reduces the risk of heart disease (2737,4960,4962,4963,4964,4965,4966,4967,4968). In 1993, the FDA approved a health claim stating that consuming products containing at least 3 grams of beta-glucans per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD (102336). However, clinical studies show that at least 3.6 grams of soluble fiber daily is needed to reduce the risk of CHD (5786,5787,5788,5794,5795,5796).
• Dyslipidemia. Oral beta-glucans modestly reduces low-density lipoprotein (LDL) cholesterol levels. Details: Although some research disagrees, most clinical research shows that taking barley- or oat-derived beta-glucans 3-10 grams daily for up to 12 weeks or yeast-derived beta-glucans 7.5 grams twice daily for 7-8 weeks can reduce LDL and total cholesterol levels when used for up to 12 weeks (5790,5796,7272,17129,34700,34727,34729,34765,34766,34811)(34812,34876). Meta-analyses of available clinical research on oat-derived beta-glucans show that taking at least 3 grams daily reduces LDL cholesterol by around 4-10 mg/dL and total cholesterol by 4-12 mg/dL but does not affect high-density lipoprotein (HDL) cholesterol or triglyceride levels when compared with control diets (92660,97987,112225). Consuming oat-derived beta-glucans also reduces apolipoprotein B (apoB) levels by 0.54 mg/dL when compared with control diets (97987). The effects of oat-derived beta-glucans on cholesterol levels appear to be greater in patients with diabetes and those with higher LDL cholesterol levels (92660,97987). A meta-analysis of available clinical research on barley-derived beta-glucans shows that consuming an average of 6.5-7 grams of beta-glucans daily as part of the diet reduces LDL cholesterol levels by 4.5 mg/dL, total cholesterol levels by 5.6 mg/dL, and apoB levels by 0.54 mg/dL when compared with control diets (98204). The form of beta-glucans used may alter the effect of beta-glucans on cholesterol levels. Some research shows that barley that is highly enriched (75% by weight) with beta-glucans does not significantly affect cholesterol levels. This lack of effect seems to be the result of processing the barley into a highly enriched beta-glucans product (10166). Other clinical research also shows that the processing of beta-glucans products or the food matrix used to make these products might reduce beta-glucans molecular weight and/or solubility and therefore decrease its ability to lower cholesterol levels (10145,34800,34819).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging. Although there is interest in using oral or topical beta-glucans for aging, there is insufficient reliable information about the clinical effects of beta-glucans for this purpose.
• Allergic rhinitis (hay fever). It is unclear if oral beta-glucans are beneficial for reducing symptoms of allergic rhinitis. Details: A small clinical trial in patients allergic to ragweed shows that taking specific yeast-derived beta-glucans (Wellmune WGP) 250 mg daily for 4 weeks decreases the number of allergy symptoms by 28% and the severity of allergy symptoms by 52% when compared with placebo (34859).
• Atopic dermatitis (eczema). It is unclear if topical beta-glucans are beneficial for atopic dermatitis. Details: Preliminary clinical research in children and adults with atopic dermatitis shows that applying a specific cream (Imunoglukan P4H, PLEURAN s.r.o.) containing beta-glucans 0.25% 2-3 times daily for 6 months modestly reduces pruritus, intensity of flares, and overall disease severity when compared with the application of a standard emollient (98201).
• Benign prostatic hyperplasia (BPH). Although there is interest in using oral beta-glucans for BPH, there is insufficient reliable information about the clinical effects of beta-glucans for this purpose.
• Cancer. Although there is interest in using oral beta-glucans for cancer, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Canker sores. It is unclear if oral beta-glucans are beneficial for canker sores. Details: Preliminary clinical research shows that taking beta-glucans 10 mg twice daily for 20 days reduces ulcer severity in patients with recurrent aphthous stomatitis when compared with placebo (34763).
• Chronic fatigue syndrome (CFS). Although there is interest in using oral beta-glucans for CFS, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Critical illness (trauma). It is unclear if oral beta-glucans are beneficial for patients with critical illness. Details: Preliminary clinical research shows that taking oat-derived beta-glucans 3 grams daily as part of enteral feeds does not reduce the length of hospital stay, mortality rate, or infection rate when compared with placebo in patients with trauma. However, the length of time on mechanical ventilation was approximately 47% shorter when compared with placebo (100186).
• Diabetes. Small clinical studies in children and adults with type 1 diabetes suggest that beta-glucans do not improve blood glucose levels. It is unclear if oral beta-glucans are beneficial for patients with type 2 diabetes. Details: Some preliminary clinical research in adults with type 2 diabetes shows that consuming oat-derived beta-glucans 3 grams daily in bread for 3 weeks improves insulin resistance and cholesterol levels when compared with control bread (34765). Other preliminary clinical research in patients with type 2 diabetes shows that consuming bread containing oat-derived beta-glucans in a ratio of 7.6 grams per 100 grams of starch daily for 6 months reduces postprandial glucose levels and glycated hemoglobin (HbA1c) when compared with control bread (97986). Additionally, some clinical research shows that replacing a half serving of white rice with beta-glucans-containing barley attenuates increases in postprandial glucose and insulin levels when compared with a full serving of white rice in patients with type 2 diabetes (103887). However, oat-derived beta-glucans 3-3.5 grams daily in bread or soup for 3-8 weeks does not seem to significantly affect fasting plasma glucose levels or HbA1c when compared with control bread or soup (34765,34788). Also, some evidence shows that consuming soup enriched with beta-glucans does not improve cholesterol levels in patients with type 2 diabetes when compared with control soup (34788). The inconsistency in clinical outcomes may be due to differences in the length of treatment, quantity or ratio of beta-glucans consumed, and/or the preparation of the beta-glucans product. In children with type 1 diabetes, consuming a bedtime snack enriched in beta-glucans appears to prevent hypoglycemia prior to midnight, but does not prevent hypoglycemia at later time points when compared with a control snack (34685). In adolescents with type 1 diabetes, a very small clinical study shows that taking a specific oat product (Betaglucare), providing 6 grams beta-glucans, in three divided doses daily for one week is beneficial for glycemic control and variability when compared with a standard diet without beta-glucans or with 3 grams beta-glucans daily. Maximal, mean, and pre- and post-meal blood glucose levels were modestly lower, and minimal blood glucose levels were modestly higher. Most measures of glycemic variability were statistically different, although there were no differences in the durations of hypoglycemia or hyperglycemia between groups (105261). However, a small crossover study in adults with type 1 diabetes shows that taking a specific product (Stomacol, Brainbridge Commerce AB) containing beta-glucans 1.53 grams 3 times daily prior to meals for 2 weeks does not alter blood glucose levels when compared with placebo (97983).
• Exercise-induced respiratory infections. There is conflicting evidence about the effects of beta-glucans on respiratory infections in athletes following competitive events. Details: Taking a specific product containing oat beta-glucans (OatVantage) 5.6 grams daily for 14 days does not reduce the number of sick days or the number of upper respiratory tract infections in trained male cyclists when compared with placebo (34746). However, other clinical research shows that taking yeast-derived beta-glucans 250-500 mg daily for 4 weeks beginning on the day after a marathon reduces the occurrence of symptomatic upper respiratory infections by 33% to 50% within 2-4 weeks of treatment when compared with placebo. Health scores, fatigue, and mood also improved (34860,92659). Additional clinical research in marathon runners shows that drinking a beverage containing yeast-derived beta-glucans 250 mg daily for 45 days prior to, the day of, and 45 days after a marathon does not reduce the duration or number of upper respiratory infections, but does seem to reduce the number of symptomatic days and overall severity of upper respiratory symptoms, when compared with placebo (103886). Finally, clinical research in top athletes also shows that taking a specific product containing mushroom-derived beta-glucans (Imunoglukan P4H, PLEURAN s.r.o.) 200 mg with vitamin C 200 mg daily for 3 months reduces the number of subjects with at least four symptoms of upper respiratory tract infection by approximately 85% when compared with vitamin C alone (34809).
• Fibromyalgia. Although there is interest in using oral beta-glucans for fibromyalgia, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Hepatitis. Although there is interest in using oral beta-glucans for hepatitis, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Hypertension. It is unclear if oral beta-glucans are beneficial for hypertension; the available evidence is conflicting. Details: Preliminary clinical research shows that consuming an oat cereal containing beta-glucans 5.52 grams daily for 6 weeks reduces diastolic and systolic blood pressure when compared with a low-fiber cereal in hypertensive adults (34691). However, other clinical research shows that consuming oat-based cereals enriched in beta-glucans for 12 weeks does not reduce blood pressure in individuals with hypertension. A reduction in blood pressure occurred in a sub-group of these individuals with a body mass index greater than 31.5 kg/m2 (34684,34722).
• Inflammatory bowel disease (IBD). Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in adults with IBD and symptoms of irritable bowel syndrome shows that taking a combination of beta-glucans, inositol, and digestive enzymes daily for 4 weeks, in conjunction with mesalamine, reduces evacuative urgency when compared with mesalamine alone. Taking this combination product also reduces abdominal pain, bloating, and gas when compared with baseline, but not when compared with taking mesalamine alone (97984).
• Irritable bowel syndrome (IBS). Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking one pill twice daily of a specific combination product (Biointol, BioActivaL) containing beta-glucans, inositol, and digestive enzymes for 4 weeks reduces pain, bloating, and gas, but not other symptoms of IBS, when compared with no treatment (34818). It is not clear if these effects are due to beta-glucans, the other ingredients, or the combination.
• Laser skin resurfacing. It is unclear if topical beta-glucans are beneficial for improving recovery from laser skin resurfacing. Details: In patients that had received fractional laser therapy for atrophic acne scars, preliminary clinical research shows that topical application of skin care products containing beta-glucans, including dressings, solutions, and creams, (Dermdoc, Songyang Biotechnology Co. Ltd) once daily to one side of the face for 14 days modestly increases hydration and reduces redness when compared with the other side of the face treated with the vehicle alone (105263).
• Lower respiratory tract infections. Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in children aged 2-6 years with recurrent respiratory tract infections shows that taking a specific combination product (Stimunex gocce) containing beta-glucans, elderberry extract, zinc, and vitamin D3 does not reduce the number or duration of lower respiratory tract infections when compared with no treatment. In the four months after treatment completion, the number of infections was reduced by about 50%; however, the total number of infections in each group was small. The dose was 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212).
• Lyme disease. Although there is interest in using oral beta-glucans for Lyme disease, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Metabolic syndrome. It is unclear if oral beta-glucans are beneficial for metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome or at high risk for metabolic syndrome shows that eating 200 grams of bread enriched with 6% barley-derived beta-glucans daily for 4 weeks as part of the diet does not alter most metabolic parameters when compared with baseline. However, there was a small reduction in total cholesterol (100185). The validity of this finding is limited by the lack of a comparator group.
• Multiple sclerosis (MS). Although there is interest in using oral beta-glucans for MS, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Neuroblastoma. It is unclear if oral beta-glucans is beneficial in children or young adults with neuroblastoma. Details: Clinical research in children and young adults with relapsed or refractory high-risk neuroblastoma shows that taking yeast-derived beta-glucans for 17 days, starting four days before treatment with intravenous anti-GD2 murine monoclonal antibody for a total of 10 days, results in progression-free and overall survival rates of 28% and 61%, respectively, after 2 years, and 19% and 36%, respectively, after 5 years. Doses of beta-glucans ranged from 10-200 mg/kg daily and each patient completed 1-4 treatment cycles (109203). The validity of these findings is limited by the lack of statistical comparison to a control group. A large clinical study in children and young adults with high-risk neuroblastoma receiving subcutaneous GD2/GD3 vaccine shows that taking beta-glucans 40 mg/kg/day for 14 days as a primer to the vaccine improves the IgG antibody response at 32 weeks when compared with controls who started taking beta-glucans 6 weeks after vaccination. However, taking beta-glucans prior to vaccination does not improve overall or progression-free survival at approximately 20 months (112227). This study may have been inadequately powered to detect a difference in survival between groups.
• Obesity. It is unclear if oral beta-glucans are beneficial for obesity. Details: A meta-analysis of 20 randomized controlled trials shows that taking beta-glucans reduces body weight by about 0.8 kg and body mass index (BMI) by about 0.6 kg/m2 when compared with not taking beta-glucans. However, there was no effect on waist circumference. Also, populations included in this meta-analysis included those with obesity, as well as healthy individuals and patients with diabetes or hypercholesterolemia (100183). Results from individual clinical trials are mixed, with some showing modest reductions in body weight, BMI, and/or waist circumference, and others showing no effect (34790,98202,98203,100183,109208). This research has evaluated barley-, oat-, or yeast-derived beta-glucans at doses between 0.88-9 grams daily for 0.4-12 weeks (34790,98202,98203,100183,109208). Also, a capsule containing yeast-derived beta-glucans 477 mg has been taken daily for 2 weeks, then twice daily for 4 weeks (98203). Beta-glucans have also been taken in combination with other ingredients. For example, barley-derived beta-glucans 2.2 grams has been mixed with rice and consumed twice daily with meals for 12 weeks (98202) and oat-derived beta-glucans (B-Can, Garuda International, Inc.) 2.5 grams has been taken with green coffee polyphenols 300 mg twice daily for 8 weeks (109208). The inconsistency in clinical outcomes may be due to the heterogenous patient populations, as well as the differing sources, doses, and dosage forms of beta-glucans used.
• Otitis media. Although there is interest in using oral beta-glucans for otitis media, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Postoperative pain. It is unclear if oral beta-glucans are beneficial for reducing abdominal pain after surgery for intestinal polyps. Details: Preliminary clinical research in patients who underwent surgical removal of intestinal polyps shows that eating bread containing barley beta-glucans 3 grams daily for 3 months reduces bloating and abdominal pain when compared with eating bread that does not contain beta-glucans (34813).
• Respiratory tract infections. Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in children aged 2-6 years with recurrent respiratory tract infections shows that taking a specific combination product (Stimunex gocce) containing beta-glucans, elderberry extract, zinc, and vitamin D3 reduces the duration of respiratory tract infections by about 1.7 days and modestly improves parent-perceived symptom severity and effectiveness when compared with no treatment. However, there was no effect on the number of total, upper, or lower respiratory tract infections, the use of antibiotics or antipyretics, or the number of days missed from school. The product was dosed as 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212).
• Rheumatoid arthritis (RA). Although there is interest in using oral beta-glucans for RA, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Stretch marks (striae distensae). It is unclear if topical beta-glucans are beneficial for stretch marks. Details: Preliminary clinical research shows that a specific topical serum and emulsion (Awake; Hangzhou Songyang Biotechnical) containing beta-glucans, applied twice daily for 12 weeks, modestly improves patient-scored, but not physician-scored, stretch mark appearance when compared with a vehicle control. When beta-glucans are used in combination with 1565-nm non-ablative fractional laser once every 4 weeks for 12 weeks, scar atrophy is modestly improved when compared with either treatment alone (109210). However, it is unclear if any changes would be considered clinically significant.
• Upper respiratory tract infection (URTI). It is unclear if oral beta-glucans are beneficial for the prevention of URTIs in adults or children. Details: A meta-analysis of clinical research shows that taking yeast-derived beta-glucans reduces the odds of developing a URTI in generally healthy individuals by approximately 65% when compared with placebo. There was also a small to medium effect on the overall incidence and duration of URTIs. Doses ranged from 35-900 mg daily for 4-26 weeks (105264). However, the results from this analysis were heterogeneous and the number of studies included was small. One study included in the analysis used a specific product containing yeast-derived beta-glucans (Wellmune WGP) 500 mg daily for 12 weeks and found no effect on the number or duration of overall symptomatic infections or the number or duration of specific types of respiratory infections when compared with placebo. However, there was an improvement in quality of life and a reduction in the number of missed work days (34879). Beta-glucans have also been evaluated for the prevention of URTI in children. A small clinical study in children aged 2-6 years with recurrent respiratory tract infections shows that taking a specific combination product (Stimunex gocce) containing beta-glucans, elderberry extract, zinc, and vitamin D3 does not reduce the number or duration of upper respiratory tract infections when compared with no treatment. At four months after treatment completion, the number of infections was reduced by about 44%; however, the total number of infections in both groups was small. The product was dosed as 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212).
• Wound healing. Although there is interest in using topical beta-glucans for healing of wounds, burns, skin ulcers, and dermatitis, there is insufficient reliable information about the clinical effects of beta-glucans for these purposes. More evidence is needed to rate beta-glucans for these uses.

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POSSIBLY EFFECTIVE

• Herpes labialis (cold sores). Most clinical research shows that oral lysine can prevent and treat herpes labialis. The benefits of topical lysine are unclear. Details: Despite one small clinical study that found no benefit (1116), most clinical research shows that taking oral lysine monohydrochloride 1000-1248 mg daily or 1000 mg three times daily reduces the recurrence of herpes labialis infections when compared with placebo (1114,1115,1118,1120,19390,19391). Also, small clinical studies show that taking oral lysine 1000 mg daily in up to two divided doses for up to 12 months or 1000 mg three times daily for 6 months reduces the severity and healing time of herpes labialis infections when compared with placebo (1119,1120). Topical lysine has also been studied in combination with other ingredients. A small, open-label study shows that applying a specific combination product containing lysine and zinc oxide plus 14 other ingredients (Super Lysine Plus +) topically every 2 hours for 11 days seems to decrease symptoms and duration of herpes lesions when compared with baseline (11051). The validity of this finding is limited by the lack of a comparator group. Also, it is unclear if any benefit is due to lysine, other ingredients, or the combination.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. Although there is interest in using oral lysine for improving athletic performance, there is insufficient reliable information about the clinical effects of lysine for this purpose.
• Canker sores. It is unclear if oral lysine is beneficial in patients with canker sores. Details: Preliminary clinical research shows that taking oral lysine 500 mg daily may be beneficial for preventing canker sores, and taking oral lysine 4000 mg daily may be beneficial for decreasing the duration of canker sores (19390).
• Child growth. Oral lysine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in children aged 4-9 years old with idiopathic short stature shows that taking a combination oral solution containing lysine, inositol, and vitamin B12 10 mL twice daily along with moderate stretching exercises for 12 months increases height, growth velocity, and serum growth indicators and reduces height standard deviation scores when compared with control. However, the combination product does not impact body mass index or the ratio of bone age to chronological age when compared with control (112280). It is unclear if these findings are due to lysine, other ingredients, or the combination.
• Diabetes. It is unclear if oral lysine is beneficial in patients with diabetes. Details: One small clinical study shows that taking lysine hydrochloride 500 mg twice daily for 2 months does not affect fasting or postprandial blood glucose levels or glycated hemoglobin in patients with type 2 diabetes when compared a calcium phosphate control (19395).
• Diabetic foot ulcers. It is unclear if topical lysine is beneficial in patients with diabetic foot ulcers. Details: A small clinical study in adults with type 2 diabetes and grade 2 diabetic foot ulcers shows that applying topical lysine 15% cream twice daily with standard treatment for 8 weeks improves the rate of wound healing and skin color surrounding the wound, and also reduces ulcer size, depth, margins, undermining, edema, induration, granulation tissue, necrotic tissue amount and type, exudate type and amount, and epithelialization when compared with control (112279). The validity of the findings is limited by a lack of blinding and small sample size.
• Hypertension. Limited clinical research shows that oral lysine can reduce blood pressure in hypertensive patients who have deficient dietary lysine intake. Details: Preliminary clinical research in malnourished people in West Africa with deficient lysine intake shows that taking lysine orally 500 mg twice daily for 16 weeks reduces systolic blood pressure (SBP) when compared with placebo in those with hypertension at baseline. The mean SBP was reduced by 17 mmHg in males and 12 mmHg in females. Lysine supplementation did not affect SBP in people who were normotensive at baseline (104104).
• Hypertriglyceridemia. It is unclear if oral lysine is beneficial for patients with hypertriglyceridemia. Details: Preliminary clinical research shows that taking lysine 1 gram daily for 12 weeks, with or without vitamin B6 50 mg daily, does not affect body weight, triglyceride levels, or blood glucose levels when compared with placebo in males with hypertriglyceridemia. Furthermore, this dose of lysine, taken alone or in combination with vitamin B6, appears to slightly decrease high-density lipoprotein (HDL) cholesterol levels after 12 weeks when compared with placebo (90642).
• Muscle strength. Higher dietary intake of lysine seems to improve muscle strength in young under- or well-nourished males. Details: Preliminary clinical research in young, under- or well-nourished males shows that consuming lysine 80 mg/kg daily in the diet for 8 weeks improves muscle strength of the forearm by approximately 7.5% when compared with a diet containing lysine 25-40 mg/kg daily (90643).
• Pressure ulcers. A small study suggests that topical lysine may be beneficial for pressure ulcers. Details: A small clinical study in hospitalized adults shows that applying a specific cream containing lysine hyaluronate (Lys-HA, Lysial, Fatai-Nyl Srl; Jasper LLC) topically with dressing changes once daily for one week, then once every 2 days for one week, reduces pressure ulcer size when compared with a cream containing sodium hyaluronate. The effect appears to be greater in patients with more advanced (stage 3) ulcers compared to less advanced (stage 1) ulcers (90641).
• Schizophrenia. Large doses of oral lysine seem to improve schizophrenia symptoms in patients taking antipsychotic medications. Details: Clinical research in people with schizophrenia not controlled by risperidone shows that taking L-lysine 2 grams three times daily for 8 weeks improves symptoms by approximately 34% when compared with placebo. Negative and psychopathologic symptoms appear to improve the most (90645). In patients stabilized on antipsychotic medications, preliminary clinical research suggests that taking L-lysine 6 grams once daily for 4 weeks improves positive symptoms of schizophrenia, particularly delusions and suspiciousness/persecution, when compared with baseline. However, this improvement was not significant when compared with placebo (90644).
• Stress. Limited clinical research in economically disadvantaged populations shows that fortifying wheat with lysine may reduce stress and anxiety. Details: Preliminary clinical research shows that consuming wheat that has been fortified with lysine 4.2 grams/kg reduces stress in females and reduces anxiety in males in economically disadvantaged populations that typically consume cereal-based diets when compared with control (19394). More evidence is needed to rate lysine for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dyspepsia. Oral olive leaf extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in healthy adults shows that taking a specific combination product containing olive leaf extract 24% and prickly pear cactus 33% (Mucosave, Bionap S.R.L.) 400 mg daily for 8 weeks seems to improve dyspepsia and other gastrointestinal symptoms when compared with placebo (105904). It is unclear if this benefit would occur in patients with clinically diagnosed dyspepsia.
• Exercise-induced respiratory infections. It is unclear if oral olive leaf extract is beneficial for reducing respiratory infections from exercise. Details: A small clinical study in high school athletes shows that taking one tablet of olive leaf extract providing eleuropein 100 mg daily for 2 months during training season does not reduce the incidence of the common cold when compared with placebo. While it may reduce the number of sick days by 28%, a sub-group analysis suggests that this reduction is only evident in female athletes (101860).
• Gastroesophageal reflux disease (GERD). Although there is interest in using oral olive leaf for GERD, there is insufficient reliable information about the clinical effects of olive for this condition.
• Herpes zoster (shingles). Although there is interest in using oral olive leaf for shingles, there is insufficient reliable information about the clinical effects of olive for this condition.
• Influenza. Although there is interest in using oral olive leaf for influenza, there is insufficient reliable information about the clinical effects of olive for this condition.
• Metabolic syndrome. It is unclear if oral olive leaf extract is beneficial for improving body composition and cardiovascular risk factors in patients with metabolic syndrome. Details: A small clinical trial in overweight, middle-aged males at risk for metabolic syndrome shows that taking four capsules of olive leaf extract providing oleuropein 51.1 mg and hydroxytyrosol 9.7 mg daily for 12 weeks improves insulin sensitivity by 15% when compared with placebo. However, body composition, blood pressure, cholesterol levels, and other cardiovascular risk factors were not improved (92245).
• Osteoarthritis. It is unclear if oral olive fruit or leaf extract is beneficial for improving osteoarthritis. Details: Preliminary clinical research shows that taking a freeze-dried aqueous extract of olive fruit 400 mg daily for 8 weeks decreases pain and increases mobility in people with osteoarthritis (14844). Other preliminary clinical research in adults with knee osteoarthritis shows that taking olive leaf extract 50.1 mg daily for 4 weeks improves overall pain measurements by 14%, compared to only 4% in the placebo group. However, many individual measurements of pain are not improved (92252).
• Osteoporosis. It is unclear if oral olive leaf extract is beneficial for osteoporosis. Details: Clinical research shows that taking olive leaf extract (Bonolive, BioActor BV) 250 mg daily for 12 months, along with elemental calcium 400 mg daily, increases osteocalcin levels by about 32% when compared to baseline; this increase was significant when compared to those taking calcium 400 mg plus placebo, who showed a 6% decrease in osteocalcin levels. However, taking olive leaf extract does not significantly increase bone mineral density of the lumbar spine or femur neck when compared with placebo (92247).
• Rheumatoid arthritis (RA). It is unclear if oral olive fruit extract is beneficial for improving RA symptoms. Details: Preliminary clinical research in adults with RA shows that taking an aqueous freeze-dried extract of olive fruit 400 mg daily for 8 weeks does not improve symptoms when compared with control (14844). More evidence is needed to rate the effectiveness of olive for these uses.

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LIKELY SAFE ...when used orally in amounts commonly found in foods. Beta-glucans derived from oat bran, baker's yeast, or brewer's yeast (Saccharomyces cerevisiae) have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally and appropriately, short-term in medicinal amounts. There is some evidence that yeast-derived beta-glucans 15 grams daily can be used safely for up to 8 weeks (7272). Oat-derived beta-glucans 3-10 grams daily can also be used safely for up to 12 weeks (7272,5796,17129,34700,34727,34729,34765,34766,34811,34812)(34876,107935,109206). ...when used topically and appropriately. A specific beta-glucans serum and emulsion (Awake; Hangzhou Songyang Biotechnical) combination has been used with apparent safely for up to 12 weeks in clinical research (109210). A specific beta-glucans cream (Imunoglukan P4H, PLEURAN s.r.o.) has been used with apparent safety 2-3 times daily for up to 6 months (98201).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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POSSIBLY SAFE ...when used orally in doses up to 3000 mg daily for up to one year (1114,1119,1120,90642,104104), or up to 6000 mg daily for up to 8 weeks (90644,90645). ...when used topically and appropriately, short-term (11051).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about LYSINE)

LIKELY SAFE ...when olive fruit is used orally and appropriately in amounts commonly found in foods.

POSSIBLY SAFE ...when olive leaf extract is used orally and appropriately. Olive leaf extract providing 51-100 mg oleuropein daily has been used with apparent safety for 6-8 weeks (92245,92247,101860). There is insufficient reliable information available about the safety of olive fruit extract when used in amounts greater than those found in foods.

PREGNANCY AND LACTATION:
Insufficient reliable information available; stick with amounts commonly found in foods.

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ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking beta-glucans with antihypertensive drugs might increase the risk of hypotension.  Details Clinical research shows that taking beta-glucans may reduce systolic and diastolic blood pressure in some hypertensive individuals (34684,34691,34722).

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, beta-glucans might interfere with immunosuppressive therapy.  Details Some clinical research shows that beta-glucans have immunostimulant effects (34809,34860,34879,92659,103886,105264).

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5-HT4 AGONISTS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, lysine may reduce the effects of 5-HT4 agonists.  Details Animal research suggests that L-lysine is a partial serotonin receptor 4 (5-HT4) antagonist and inhibits diarrhea induced by the 5-HT4 agonist, 5-hydroxytryptophane (19400).

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General ...Orally and topically, beta-glucans seem to be well-tolerated.
Most Common Adverse Effects:
Topically: Contact dermatitis, skin reactions.

Dermatologic ...Topically, a specific beta-glucans cream r.o.) has been reported to cause skin reactions and contact dermatitis in one clinical trial. These reactions occurred in 27% of patients; reactions were mild and self-limiting in 12% of patients (98201).

Hematologic ...In one clinical trial of children and young adults with neuroblastoma, one of 44 patients developed transient elevations of aspartate transaminase and alanine transaminase within five days of starting oral beta-glucans 120 mg/kg daily (109203).

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General ...Orally and topically, lysine is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, and dyspepsia.

Gastrointestinal ...Orally, lysine has been reported to cause diarrhea and abdominal pain, including dyspepsia (1114,1115,1116,1118,1120).

Renal ...There is one case report of oral lysine use associated with tubulointerstitial nephritis progressing to chronic renal failure in a 44-year old female (1121).

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General ...Orally, olive fruit is well tolerated when used in typical food amounts. Olive leaf extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Headache and stomach discomfort.

Dermatologic ...Orally, one patient in one clinical trial reported bad skin and acne after using olive leaf extract (101860).

Gastrointestinal ...Orally, three patients in one clinical trial reported stomach ache after using olive leaf extract (101860).

Neurologic/CNS ...Orally, three patients in one clinical trial reported headache after using olive leaf extract (101860).

Psychiatric ...In one case report, a 67-year-old female experienced irritability, anger, a lack of control, and feelings of sadness and negativity after consuming a multi-ingredient product containing olive leaf extract 5 grams, horseradish root, and eyebright daily for 38 days. All psychiatric symptoms disappeared within days of stopping the combined product. It is hypothesized that the hydroxytyrosol component of olive leaf extract contributed to these symptoms due to its chemical similarity to dopamine; however, it is not clear if these symptoms were due to the olive leaf extract or to the other ingredients (96245).

Pulmonary/Respiratory ...Olive tree pollen can cause seasonal respiratory allergy (1543).

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