NCT01162213

CompletedPhase 1

Pilot Study of Lychee Fruit Extract to Promote Cardiovascula...

University of California, Davis Source

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Other study identifiers

Sponsor study identifier

200916915-2

Study Type

interventional

Actual enrollment (reported)

44

Locations

1 country

Sites

1

Timeline

Study Start

April 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2010

Actual (reported)

Study Completion

July 2010

Actual (reported)

Brief Summary

The investigators hypothesize that acute and short term consumption of a lychee fruit extract, particularly rich in low molecular weight dietary flavanols, will improve vascular function and reduce platelet reactivity.

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): 44 participants
Study completion date: July 2010
Actual (reported)
Listed locations: 1 countries · 1 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
April 2009
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)
Study Completion
July 2010
Actual (reported)
First Submitted
July 12, 2010
Actual (reported)
First Posted
July 14, 2010
Actual (reported)

Last Updated: August 23, 2010
Status Verified: August 2010
Last Update Submitted: August 19, 2010

Conditions

Cardiovascular Health

Keywords

Postmenopausal WomenHealthy MalesCardiovascularFlavanols

Outcome Measures

Primary Outcomes (1)

Peripheral Arterial Tonometry
0, 2 and 4 hours

Study Arms (4)

100 mg of Lychee fruit extract

EXPERIMENTAL

Dietary Supplement: Lychee Fruit Extract

200 mg of Lychee fruit extract

EXPERIMENTAL

Dietary Supplement: Lychee Fruit Extract

600 mg of Lychee fruit extract

EXPERIMENTAL

Dietary Supplement: Lychee Fruit Extract

2000 mg of Lychee fruit extract

Interventions

Lychee Fruit ExtractDietary supplement

placebo or 100, 200 and 600 mg of lychee fruit extract for 2 weeks with one week washout period between treatments 2000 mg of lychee fruit extract given at a single visit

100 mg of Lychee fruit extract200 mg of Lychee fruit extract2000 mg of Lychee fruit extract600 mg of Lychee fruit extract

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

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female Age 52 to 65 yrs.
Male Age 18 to 35 yrs.

Sponsors & Collaborators

University of California, Davis
Otherlead

Study Sites (1)

Ragle Human Nutrition Research Center

Davis, California, 95616, United States

Study Officials

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

Enrollment

44 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

April 2009

Date type not reported

This date has not been verified as actual or estimated.

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EXPERIMENTAL

Dietary Supplement: Lychee Fruit Extract

Female and male \>110 pounds

Lack of menses in the last year and FSH 23-116.3 mIU/mL

Subject is willing and able to comply with the study protocols.

Subject is willing to consume the lychee fruit extract or placebo capsule twice a day.

BMI 20-35 kg/m2

You may not qualify if:

Physical signs of health impairment
Weight \< 110 pounds
BMI \>35 kg/m2
Blood Pressure \> 140/90 mm Hg
Diabetes
Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
Abnormal clinical laboratory test (CBC, comprehensive metabolic panel, etc.) if determined to be clinically significant by Dr. M. Eric Gershwin.
PFA-100 readings 10% outside of normal reference range (normal reference range for ADP-Collagen cartridge: 71-118 sec; Epinephrine-Collagen cartridge: 94-193 sec).
Inflammatory disorders (e.g. rheumatoid arthritis)
Malabsorption
Treatment with corticosteroids, hypolipidemic and anti-inflammatory drugs
Renal or liver disease
History of cancer
Heart disease, which includes cardiovascular events and Stroke
Cushing's syndrome
+11 more criteria

Contact the study team to confirm eligibility.

Primary Completion

July 2010

Actual (reported)

Study Completion

July 2010

Actual (reported)

Last Updated

August 23, 2010

Record last verified: 2010-08

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: NCT01162213
Data provider: ClinicalTrials.gov
Source updated: 2010-08-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:41 UTC

Locations

US(1)

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 (4)

100 mg of Lychee fruit extract

200 mg of Lychee fruit extract

600 mg of Lychee fruit extract

2000 mg of Lychee fruit extract

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations