Trial | NCT01162174  Report issue

Title

Pilot Study of Oligonol Supplementation to Promote Cardiovascular Health
Effects of Oligonol on Vascular Function and Inflammation in Healthy Men: A Double-Blind, Dose-Finding Study

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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.
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.
Study Started
Aug 31
2008
Primary Completion
Feb 28
2009
Study Completion
Feb 28
2009
Last Update
Jul 14
2010
Estimate

Dietary Supplement Oligonol

100 mg of Oligonol Experimental

200 mg of Oligonol Experimental

0 mg of Oligonol Placebo Comparator

Criteria 

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
No Results Posted