Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health
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ClinicalTrials.gov Identifier: NCT01162213 |
Recruitment Status :
Completed
First Posted : July 14, 2010
Last Update Posted : August 23, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Health | Dietary Supplement: Lychee Fruit Extract | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | April 2009 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |
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 |
- Peripheral Arterial Tonometry [ Time Frame: 0, 2 and 4 hours ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162213
United States, California | |
Ragle Human Nutrition Research Center | |
Davis, California, United States, 95616 |
Principal Investigator: | Robert M Hackman, PhD | University of California, Davis |
Responsible Party: | Robert M Hackman, Nutrition Department, University of California, Davis |
ClinicalTrials.gov Identifier: | NCT01162213 |
Other Study ID Numbers: |
200916915-2 |
First Posted: | July 14, 2010 Key Record Dates |
Last Update Posted: | August 23, 2010 |
Last Verified: | August 2010 |
Postmenopausal Women Healthy Males Cardiovascular Flavanols |