NCT01162174

CompletedPhase 1

Pilot Study of Oligonol Supplementation to Promote Cardiovas...

University of California, Davis Source

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Other study identifiers

Sponsor study identifier

200816212-1

Study Type

interventional

Actual enrollment (reported)

16

Locations

0 countries

Sites

N/A

Timeline

Study Start

August 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2009

Actual (reported)

Study Completion

February 2009

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 16 participants
Study completion date: February 2009
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2008
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
February 2009
Actual (reported)
Study Completion
February 2009
Actual (reported)
First Submitted
July 12, 2010
Actual (reported)
First Posted
July 14, 2010
Actual (reported)

Last Updated: July 14, 2010
Status Verified: July 2010
Last Update Submitted: July 13, 2010

Conditions

Cardiovascular Health

Keywords

Flavanolscardiovascular

Outcome Measures

Primary Outcomes (1)

Peripheral Arterial Tonometry
0 and 2 hours

Study Arms (3)

100 mg of Oligonol

EXPERIMENTAL

Dietary Supplement: Oligonol

200 mg of Oligonol

EXPERIMENTAL

Dietary Supplement: Oligonol

0 mg of Oligonol

PLACEBO COMPARATOR

Dietary Supplement: Oligonol

Interventions

OligonolDietary supplement

0 mg of Oligonol100 mg of Oligonol200 mg of Oligonol

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Age 18-50 yrs.
Healthy, not taking prescription medications

Sponsors & Collaborators

Amino Up Chemical Company
Industrycollaborator
University of California, Davis
Otherlead

MeSH Terms

Interventions

oligonol

Study Officials

Robert M Hackman, PhD
University of California, Davis
PRINCIPAL INVESTIGATOR

Enrollment

16 participants (actual enrollment reported by the registry).

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 2008

Date type not reported

This date has not been verified as actual or estimated.

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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.

Primary Completion

February 2009

Actual (reported)

Study Completion

February 2009

Actual (reported)

Last Updated

July 14, 2010

Record last verified: 2010-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01162174
Data provider: ClinicalTrials.gov
Source updated: 2010-07-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:59 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

100 mg of Oligonol

200 mg of Oligonol

0 mg of Oligonol

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record