Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health - Full Text View

Purpose

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	Intervention	Phase
Cardiovascular Health	Dietary Supplement: Lychee Fruit Extract	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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

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

Primary Outcome Measures:

Peripheral Arterial Tonometry [ Time Frame: 0, 2 and 4 hours ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	April 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162213

Locations

United States, California
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

More Information

No publications provided

Responsible Party:	Robert M Hackman, Nutrition Department, University of California, Davis
ClinicalTrials.gov Identifier:	NCT01162213 History of Changes
Other Study ID Numbers:	200916915-2
Study First Received:	July 12, 2010
Last Updated:	August 19, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Postmenopausal Women
Healthy Males
Cardiovascular
Flavanols

ClinicalTrials.gov processed this record on May 23, 2013