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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01162174
Enrollment
16
Registered
2010-07-14
Start date
2008-08-31
Completion date
2009-02-28
Last updated
2010-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Health

Keywords

Flavanols, cardiovascular

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.

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.

Interventions

DIETARY_SUPPLEMENTOligonol

Sponsors

Amino Up Chemical Company
CollaboratorINDUSTRY
University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Peripheral Arterial Tonometry0 and 2 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026