Clinical evaluation of Emblica Officinalis Gatertn (Amla) in healthy human subjects: Health benefits and safety results from a randomized, double-blind, crossover placebo-controlled study

Extracts of Phaseolus vulgaris (beans) are known to reduce glycaemia and food intake in rodents and humans. The present study evaluated the effects of a new, standardised and purified P. vulgaris extract (PVE), when employed as a supplement in a mixed balanced meal (60 % carbohydrates, 25 % lipids and 15 % protein), on glycometabolic and appetite control. To this end, a randomised, double-blind, placebo-controlled study was performed in twelve volunteers. Plasma glucose, insulin, C-peptide, ghrelin and satiety sensation ratings were assessed at baseline and during 3 h after meal consumption associated with PVE (100 mg) or placebo. Compared with placebo, PVE consumption resulted in lower increments in glucose (+15·4 (sem 5·4) v. 26·1 (sem 7·3) %, P= 0·04 at 30 min), insulin (+981 (sem 115) v. 1325 (sem 240) %, P= 0·04 between 45 and 120 min) and C-peptide (+350 (sem 27) v. 439 (sem 30) %, P= 0·04 between 30 and 90 min). In the first 2 h, plasma ghrelin decreased similarly in both groups but did not rebound as in placebo thereafter (P= 0·04). Correspondingly, satiety sensation in the third hour was significantly reduced in the placebo but not in the PVE condition. PVE induced a lower desire to eat than placebo (P= 0·02) over the 3 h. In conclusion, PVE supplementation reduced postprandial glucose, insulin and C-peptide excursions, suppressed ghrelin secretion and affected satiety sensations, inducing a lower desire to eat. These results support that further studies are needed to prove the concept of employing PVE as a supplement in mixed balanced meals in obese, glucose-intolerant and diabetic subjects.

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Oxidised fish oil does not influence established markers of oxidative stress in healthy human subjects: a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114511005484 ◽

2011 ◽

Vol 108 (2) ◽

pp. 315-326 ◽

Cited By ~ 47

Author(s):

Inger Ottestad ◽

Gjermund Vogt ◽

Kjetil Retterstøl ◽

Mari C. Myhrstad ◽

John-Erik Haugen ◽

...

Keyword(s):

Oxidative Stress ◽

Lipid Peroxidation ◽

Fish Oil ◽

Human Subjects ◽

Controlled Study ◽

Healthy Human ◽

Significant Difference ◽

Healthy Human Subjects ◽

Markers Of Oxidative Stress ◽

Randomised Controlled

Intake of fish oil reduces the risk of CHD and CHD deaths. Marine n-3 fatty acids (FA) are susceptible to oxidation, but to our knowledge, the health effects of intake of oxidised fish oil have not previously been investigated in human subjects. The aim of the present study was to investigate markers of oxidative stress, lipid peroxidation and inflammation, and the level of plasma n-3 FA after intake of oxidised fish oil. In a double-blinded randomised controlled study, healthy subjects (aged 18–50 years, n 54) were assigned into one of three groups receiving capsules containing either 8 g/d of fish oil (1·6 g/d EPA+DHA; n 17), 8 g/d of oxidised fish oil (1·6 g/d EPA+DHA; n 18) or 8 g/d of high-oleic sunflower oil (n 19). Fasting blood and morning spot urine samples were collected at weeks 0, 3 and 7. No significant changes between the different groups were observed with regard to urinary 8-iso-PGF2α; plasma levels of 4-hydroxy-2-hexenal, 4-hydroxy-2-nonenal and α-tocopherol; serum high sensitive C-reactive protein; or activity of antioxidant enzymes in erythrocytes. A significant increase in plasma level of EPA+DHA was observed in both fish oil groups, but no significant difference was observed between the fish oil groups. No changes in a variety of in vivo markers of oxidative stress, lipid peroxidation or inflammation were observed after daily intake of oxidised fish oil for 3 or 7 weeks, indicating that intake of oxidised fish oil may not have unfavourable short-term effects in healthy human subjects.

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Dietary SupplementS-Adenosyl-l-Methionine (AdoMet) Effects on Plasma Homocysteine Levels in Healthy Human Subjects: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial

The Journal of Alternative and Complementary Medicine ◽

10.1089/acm.2008.0402 ◽

2009 ◽

Vol 15 (5) ◽

pp. 523-529 ◽

Cited By ~ 10

Author(s):

Michael A. Thompson ◽

Brent A. Bauer ◽

Laura L. Loehrer ◽

Stephen S. Cha ◽

Jayawant N. Mandrekar ◽

...

Keyword(s):

Clinical Trial ◽

Dietary Supplements ◽

Randomized Clinical Trial ◽

Human Subjects ◽

Plasma Homocysteine ◽

Healthy Human ◽

Double Blind ◽

Double Blind Placebo ◽

Healthy Human Subjects

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4-Methylpyrazole: A Controlled Study of Safety in Healthy Human Subjects after Single, Ascending Doses

Alcoholism Clinical and Experimental Research ◽

10.1111/j.1530-0277.1988.tb00235.x ◽

1988 ◽

Vol 12 (4) ◽

pp. 516-522 ◽

Cited By ~ 59

Author(s):

Dag Jacobsen ◽

C. Simon Sebastian ◽

Rolf Blomstrand ◽

Kenneth E. McMartin

Keyword(s):

Human Subjects ◽

Controlled Study ◽

Healthy Human ◽

Healthy Human Subjects

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A randomised, double- blind, cross-over study investigating the prebiotic effect of agave fructans in healthy human subjects

Journal of Nutritional Science ◽

10.1017/jns.2014.68 ◽

2015 ◽

Vol 4 ◽

Cited By ~ 25

Author(s):

P. Ramnani ◽

A. Costabile ◽

A. G. R. Bustillo ◽

G. R. Gibson

Keyword(s):

Denaturing Gradient Gel Electrophoresis ◽

Human Subjects ◽

Secretory Iga ◽

Healthy Human ◽

Double Blind ◽

Bacterial Populations ◽

Healthy Human Subjects ◽

Gradient Gel Electrophoresis

AbstractThis placebo-controlled, randomised, double-blind, cross-over human feeding study aimed to determine the prebiotic effect of agave fructans. A total of thirty-eight volunteers completed this trial. The treatment consisted of 3 weeks' supplementation with 5 g/d of prebiotic agave fructan (Predilife) or equivalent placebo (maltodextrin), followed by a 2-week washout period following which subjects were crossed over to alternate the treatment arm for 3 weeks followed by a 2-week washout. Faecal samples were collected at baseline, on the last day of treatment (days 22 and 58) and washout (days 36 and 72), respectively. Changes in faecal bacterial populations, SCFA and secretory IgA were assessed using fluorescentin situhybridisation, GC and ELISA, respectively. Bowel movements, stool consistencies, abdominal comfort and mood changes were evaluated by a recorded daily questionnaire. In parallel, the effect of agave fructans on different regions of the colon using a three-stage continuous culture simulator was studied. Predilife significantly increased faecal bifidobacteria (log109·6 (sd0·4)) and lactobacilli (log107·7 (sd0·8)) compared with placebo (log109·2 (sd0·4);P = 0·00) (log107·4 (sd0·7);P= 0·000), respectively. No change was observed for other bacterial groups tested, SCFA, secretory IgA, and PGE2concentrations between the treatment and placebo. Denaturing gradient gel electrophoresis analysis indicated that bacterial communities were randomly dispersed and no significant differences were observed between Predilife and placebo treatments. Thein vitromodels showed similar increases in bifidobacterial and lactobacilli populations to that observed with thein vivotrial. To conclude, agave fructans are well tolerated in healthy human subjects and increased bifidobacteria and lactobacilli numbersin vitroandin vivobut did not influence other products of fermentation.

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A Comparative Pharmacokinetic Evaluation of a Bioavailable Curcumin Formulation Curene® with Curcumin Formulation Containing Turmeric Volatile Oil and Standard Curcuminoids 95% in Healthy Human Subjects

Functional Foods in Health and Disease ◽

10.31989/ffhd.v9i2.548 ◽

2019 ◽

Vol 9 (2) ◽

pp. 134

Author(s):

Sanjib Kumar Panda ◽

Somashekara ◽

Vivek A. Parachur ◽

Nilima Mohanty ◽

Tathastu Swain ◽

...

Keyword(s):

Human Subjects ◽

Health Benefits ◽

Volatile Oil ◽

Relative Bioavailability ◽

Healthy Male ◽

Open Label ◽

Healthy Human ◽

Comparative Pharmacokinetic ◽

Reference Treatment ◽

Healthy Human Subjects

Background: Curcumin, a major active component of turmeric, which is one of the most studied botanicals for its numerous health benefits and higher safety profile. In spite of its potent clinical health benefits, its applications are circumscribed due to its poor bioavailability. The current study was carried out to compare the oral bioavailbility of newly developed bioavailable curcumin formulation Curene® with Curcumin formulation containing turmeric volatile oil (CP-01) and Standard Curcuminoids 95% in healthy human volunteers.Methods: In this current open-label, randomized, three treatments, single oral dose, single period, parallel, comparative pharmacokinetics study, 12 healthy male volunteers participated. The test product Curene® (T), reference products CP-01(Reference treatment-R1) and Standard Curcuminoids 95% (Reference treatment-R2) were orally administrated as a single dose of 3 grams per subject. Plasma samples were withdrawn from each subject at predetermined timepoints and samples were analyzed by LC-MS/MS. Results: Based on the pharmacokinetics data, the relative bioavailability (Free Curcumin; AUC0-t) of Curene® was found to be ~112.7 times more when compared to the standard Curcuminoids (R2).Conclusion: The oral bioavailability of Curene® was found to be significantly higher compared to CP-01and Standard Curcuminoids (95%) furthermore, it was also found to be safe in healthy human subjects under the study conditions.

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Double-Blind, Placebo-Controlled, Randomized Clinical Trial of the Effect of the Dietary Supplement S-Adenosyl-L-Methionine (AdoMet) on Plasma Homocysteine (Hcy) Levels in Healthy Human Subjects.

Blood ◽

10.1182/blood.v108.11.1481.1481 ◽

2006 ◽

Vol 108 (11) ◽

pp. 1481-1481

Author(s):

Michael A. Thompson ◽

Brent A. Bauer ◽

Laura L. Loehrer ◽

Stephen S. Cha ◽

Jayawant N. Mandrekar ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Randomized Clinical Trial ◽

Primary Endpoint ◽

Human Subjects ◽

Nutritional Supplement ◽

Healthy Human ◽

Double Blind ◽

Double Blind Placebo ◽

Healthy Human Subjects

Abstract BACKGROUND: S-adenosyl-L-methionine (AdoMet or SAM-e®) is a commonly used nutritional supplement available in the United States since 1999. AdoMet is metabolized to homocysteine (Hcy), a potential cardiovascular risk factor. A few open-label, single-arm studies have reported on the effect of exogenous AdoMet on the levels of Hcy in humans; however, this has not been tested in a double-blind, randomized clinical trial. As a nutritional supplement, AdoMet is subject only to limited regulation by the FDA, despite being used to treat clinical diseases such as depression and osteoarthritis. AdoMet is the methyl donor for small molecule, DNA, RNA, and protein methylation reactions; therefore, further understanding the biology of the AdoMet/Hcy system is important. We hypothesized that exogenous AdoMet would increase plasma Hcy levels. METHODS: In a double-blind, placebo-controlled, randomized clinical trial, 93 healthy human subjects were screened and 52 were treated with placebo (26) or 800 mg per day AdoMet (26) pills for 4 weeks. Pre- and post-treatment Hcy levels were measured. The primary endpoint was change in Hcy level. Secondary endpoints included an interim Hcy level, high sensitivity C-reactive protein (hsCRP) levels, lipid profile, and transaminases. Exclusion criteria included pregnancy and concurrent use of medications associated with changes in Hcy. RESULTS: Of 52 subjects enrolled, 45 were evaluable at the end of treatment. Subject characteristics and dropout rates were similar between placebo and control groups. Adverse events were minor and were not different between placebo and AdoMet. The primary endpoint, change in Hcy, was not significantly different between the groups (mean (umol/L), baseline: 7.43 (placebo), 8.25 (AdoMet), P=0.358; 4 week: 7.66 (placebo), 8.06 (AdoMet), P = 0.683; Baseline − 4 week: 0.23 (placebo), −0.19 (AdoMet), P = 0.427). No statistically significant difference in change in Hcy or hsCRP at 2 or 4 weeks was noted. This was true for both absolute differences as well as relative percent changes. A small decrease in ALT was observed at 2 weeks in the AdoMet group compared to the placebo group (P = 0.027). AdoMet is used in the treatment of liver diseases. There was a small, but statistically significant (P = 0.028) decrease in total cholesterol in the AdoMet group as compared to the placebo group. Interestingly, a subject with the highest baseline Hcy level had a decline in Hcy on AdoMet. Study limitations include no evaluation of AdoMet serum levels or measurement of the effect of AdoMet on DNA methylation patterns. CONCLUSIONS: AdoMet seems well tolerated and in a dose of 800 mg/day for 4 weeks does not appear to significantly affect Hcy levels in the blood. Future clinical trials of AdoMet should monitor Hcy levels with extended use of AdoMet to confirm its safety with long term use. Clinicaltrials.gov ID: NCT00284011.

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