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Pilot Study of Oligonol Supplementation to Promote Cardiovascular Health

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01162174
First Posted: July 14, 2010
Last Update Posted: July 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amino Up Chemical Company
Information provided by:
University of California, Davis
  Purpose
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.

Condition Intervention Phase
Cardiovascular Health Dietary Supplement: Oligonol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Oligonol on Vascular Function and Inflammation in Healthy Men: A Double-Blind, Dose-Finding Study

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Peripheral Arterial Tonometry [ Time Frame: 0 and 2 hours ]

Enrollment: 16
Study Start Date: August 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100 mg of Oligonol Dietary Supplement: Oligonol
Experimental: 200 mg of Oligonol Dietary Supplement: Oligonol
Placebo Comparator: 0 mg of Oligonol Dietary Supplement: Oligonol

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162174


Sponsors and Collaborators
University of California, Davis
Amino Up Chemical Company
Investigators
Principal Investigator: Robert M Hackman, PhD University of California, Davis
  More Information

Responsible Party: Carl L Keen, University of California, Davis
ClinicalTrials.gov Identifier: NCT01162174     History of Changes
Other Study ID Numbers: 200816212-1
First Submitted: July 12, 2010
First Posted: July 14, 2010
Last Update Posted: July 14, 2010
Last Verified: July 2010

Keywords provided by University of California, Davis:
Flavanols
cardiovascular