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Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01162213
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : August 23, 2010
Sponsor:
Information provided by:
University of California, Davis

Tracking Information
First Submitted Date  ICMJE July 12, 2010
First Posted Date  ICMJE July 14, 2010
Last Update Posted Date August 23, 2010
Study Start Date  ICMJE April 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
Peripheral Arterial Tonometry [ Time Frame: 0, 2 and 4 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health
Official Title  ICMJE Effects of Lychee Fruit Extract on Vascular Function and Inflammation in Postmenopausal Women: a Double-Blind, Crossover Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Cardiovascular Health
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: 100 mg of Lychee fruit extract
    Intervention: Dietary Supplement: Lychee Fruit Extract
  • Experimental: 200 mg of Lychee fruit extract
    Intervention: Dietary Supplement: Lychee Fruit Extract
  • Experimental: 600 mg of Lychee fruit extract
    Intervention: Dietary Supplement: Lychee Fruit Extract
  • Experimental: 2000 mg of Lychee fruit extract
    Intervention: Dietary Supplement: Lychee Fruit Extract
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2010)
44
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2010)
80
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162213
Other Study ID Numbers  ICMJE 200916915-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert M Hackman, Nutrition Department, University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert M Hackman, PhD University of California, Davis
PRS Account University of California, Davis
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP