Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health

NCT01162213 | Completed Phase 1

• 1 other identifier: 200916915-2
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Health

Keywords

Postmenopausal Women; Healthy Males; Cardiovascular; Flavanols

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

EXPERIMENTAL

Dietary Supplement: Lychee Fruit Extract

Interventions

Lychee Fruit Extract DIETARY_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 extract; 200 mg of Lychee fruit extract; 2000 mg of Lychee fruit extract; 600 mg of Lychee fruit extract

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Ragle Human Nutrition Research Center

Davis, California, 95616, United States

Location

Study Officials

• Robert M Hackman, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

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 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 23, 2010

Record last verified: 2010-08

Locations

US (1)