Status:
COMPLETED
Pilot Study of Oligonol Supplementation to Promote Cardiovascular Health
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Amino Up Chemical Company
Conditions:
Cardiovascular Health
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 fro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01162174
Start Date
August 1 2008
End Date
February 1 2009
Last Update
July 14 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.