Status:
COMPLETED
Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health
Lead Sponsor:
University of California, Davis
Conditions:
Cardiovascular Health
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 pl...
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, dia...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01162213
Start Date
April 1 2009
End Date
July 1 2010
Last Update
August 23 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ragle Human Nutrition Research Center
Davis, California, United States, 95616