- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01162174
Pilot Study of Oligonol Supplementation to Promote Cardiovascular Health
July 13, 2010 updated by: University of California, Davis
Effects of Oligonol on Vascular Function and Inflammation in Healthy Men: A Double-Blind, Dose-Finding Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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 Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 100 mg of Oligonol
|
|
Experimental: 200 mg of Oligonol
|
|
Placebo Comparator: 0 mg of Oligonol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peripheral Arterial Tonometry
Time Frame: 0 and 2 hours
|
0 and 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert M Hackman, PhD, University of California, Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
July 12, 2010
First Submitted That Met QC Criteria
July 13, 2010
First Posted (Estimate)
July 14, 2010
Study Record Updates
Last Update Posted (Estimate)
July 14, 2010
Last Update Submitted That Met QC Criteria
July 13, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 200816212-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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