Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health

Completed · Phase 1 · Has a placebo group

Conditions studied: Cardiovascular Health

In brief

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.

Key facts

Study ID

NCT01162213

Run by

University of California, Davis

People needed

44

Starts

2009-04-01

Expected to finish

2010-07-01

Last updated by the study team

2010-08-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• Ragle Human Nutrition Research Center — Davis, California, United States

Full record on ClinicalTrials.gov

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