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
1 other identifier
interventional
16
0 countries
N/A
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 function, reduce platelet reactivity and increase circulating levels of flavonoids after a single intake.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2008
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 12, 2010
CompletedFirst Posted
Study publicly available on registry
July 14, 2010
CompletedJuly 14, 2010
July 1, 2010
6 months
July 12, 2010
July 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peripheral Arterial Tonometry
0 and 2 hours
Study Arms (3)
100 mg of Oligonol
EXPERIMENTAL200 mg of Oligonol
EXPERIMENTAL0 mg of Oligonol
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- Amino Up Chemical Companycollaborator
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Robert M Hackman, PhD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 12, 2010
First Posted
July 14, 2010
Study Start
August 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
July 14, 2010
Record last verified: 2010-07