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OpenTrials
Completed

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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Key information

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

Oligonol

Dietary Supplement

Primary outcomes

  1. 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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