Pilot Study of Oligonol Supplementation to Promote Cardiovascular Health

Study Overview
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Brief Summary
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The investigators hypothesize that acute consumption of Oligonol, a patented lychee fruit extract (Amino Up Chemical Co.) particularly rich in low molecular weight flavanols, will improve endothelial function, reduce platelet reactivity and increase circulating levels of flavonoids after a single intake.

Detailed Description
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The investigators have demonstrated from previous studies at UC Davis that a single dose of a high-flavanol supplement from cocoa can improve endothelial function, measured by increased blood flow from peripheral arterial tonometry (PAT), reduce platelet reactivity, and increase circulating levels of flavonoids in the blood. The investigators seek with this proposal to determine if a similar response can be noted with a different high-flavanol supplement in normal, healthy people.

Official Title
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Effects of Oligonol on Vascular Function and Inflammation in Healthy Men: A Double-Blind, Dose-Finding Study

Conditions
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Cardiovascular Health

Intervention / Treatment
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* Dietary Supplement: Oligonol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-50 yrs. Healthy, not taking prescription medications Subject is willing and able to comply with the study protocols. Subject is willing to consume the Oligonol extract drink or placebo once a week for each of three weeks. Exclusion Criteria: Physical signs of health impairment. Abnormal clinical laboratory (CBC, chemistry, liver, etc.) values if determined to be clinically significant by Dr. Eric Gershwin Inflammatory disorders (e.g. rheumatoid arthritis) Malabsorption Treatment with corticosteroids, hypolipidemic and anti-inflammatory drugs Renal or Liver disease Heart Disease, which includes cardiovascular events and stroke Cushing's syndrome History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year. Anti-anxiety medications Routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids, ACE-inhibitors, and beta-blockers, erectile dysfunction drugs. Asthma (can be worsened by mild to moderate food allergies). Indications of substance or alcohol abuse within the last 3 years Undergoing nicotine cessation therapy Multi-Vitamin and mineral use other than a One-A-Day type formula Current, consistent use of herbal or plant-based supplements; omega-3 fatty acids, and fish or unwilling to discontinue use while participating in the study. Alcohol consumption > 1 oz/day (2 beers/day or 2 glasses of wine/ day, 1 drink of hard liquor/day) Chronic high-intensity exercise Smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 mg of Oligonol<br> | Dietary Supplement: Oligonol<br> <br> |
| Experimental: 200 mg of Oligonol<br> | Dietary Supplement: Oligonol<br> <br> |
| Placebo Comparator: 0 mg of Oligonol<br> | Dietary Supplement: Oligonol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Arterial Tonometry |  | 0 and 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flavanols, cardiovascular