Pilot Study of Oligonol Supplementation to Promote Cardiovascular Health

This study has been completed.
Sponsor:
Collaborator:
Amino Up Chemical Company
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01162174
First received: July 12, 2010
Last updated: July 13, 2010
Last verified: July 2010

July 12, 2010
July 13, 2010
August 2008
February 2009   (final data collection date for primary outcome measure)
Peripheral Arterial Tonometry [ Time Frame: 0 and 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01162174 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Cardiovascular Health
Dietary Supplement: Oligonol
  • Experimental: 100 mg of Oligonol
    Intervention: Dietary Supplement: Oligonol
  • Experimental: 200 mg of Oligonol
    Intervention: Dietary Supplement: Oligonol
  • Placebo Comparator: 0 mg of Oligonol
    Intervention: Dietary Supplement: Oligonol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01162174
200816212-1
No
Carl L Keen, University of California, Davis
University of California, Davis
Amino Up Chemical Company
Principal Investigator: Robert M Hackman, PhD University of California, Davis
University of California, Davis
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP