Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health

Sponsor

University of California, Davis (Other)

Overall Status

Completed

CT.gov ID

NCT01162213

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Health	Dietary Supplement: Lychee Fruit Extract	Phase 1

Detailed Description

Several large-scale epidemiologic studies have indicated that chronic consumption of flavonoid-rich foods appear to be associated with decreased risk for several chronic diseases including cancer, diabetes, cardiovascular disease, and stroke. In humans, consumption of several flavonoid-rich foods and beverages, such as berries, teas, cocoa, and grapes have been reported to improve vascular endothelial function and decrease platelet reactivity. Previous work at UC Davis by Dr. Keen and colleagues has helped define the role of flavanols in vascular function, and has used a flavanol-rich cocoa extract as the test material. In this proposed study, we seek to explore the role of a lychee fruit extract rich in flavanols, and its effects of vascular and metabolic parameters.

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Effects of Lychee Fruit Extract on Vascular Function and Inflammation in Postmenopausal Women: a Double-Blind, Crossover Study

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 100 mg of Lychee fruit extract	Dietary Supplement: Lychee Fruit Extract 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
Experimental: 200 mg of Lychee fruit extract	Dietary Supplement: Lychee Fruit Extract 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
Experimental: 600 mg of Lychee fruit extract	Dietary Supplement: Lychee Fruit Extract 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
Experimental: 2000 mg of Lychee fruit extract	Dietary Supplement: Lychee Fruit Extract 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

Outcome Measures

Primary Outcome Measures

Peripheral Arterial Tonometry [0, 2 and 4 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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
History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year.
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
Asthma (can be worsened by mild to moderate food allergies)
Indications of substance or alcohol abuse within the last 3 years
Multi-vitamin and mineral use other than a general formula, once per day tablet
Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils in the past 3-6 months, and 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)
Allergies to fruit
Chronic/routine high-intensity exercise
Smoking or actively in smoking cessation therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ragle Human Nutrition Research Center	Davis	California	United States	95616

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator: Robert M Hackman, PhD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01162213

Other Study ID Numbers:

200916915-2

First Posted:

Jul 14, 2010

Last Update Posted:

Aug 23, 2010

Last Verified:

Aug 1, 2010

Keywords provided by , ,

Study Results

No Results Posted as of Aug 23, 2010