NCT Number: NCT01162174
Pilot Study of Oligonol Supplementation to Promote Cardiovascular Health
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.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Peripheral Arterial Tonometry
Time frame: 0 and 2 hours
Sponsors and collaborators
Lead sponsor
University of California, Davis
Other
Collaborators
- Amino Up Chemical Company
Registry information
Official study title
Effects of Oligonol on Vascular Function and Inflammation in Healthy Men: A Double-Blind, Dose-Finding Study
Important dates
- Study start
- 2008
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Jul 14, 2010
- Registry last updated
- Jul 14, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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