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A Grapefruit Feeding Trial in Healthy, Overweight Adults

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ClinicalTrials.gov Identifier: NCT01452841
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : October 17, 2011
Sponsor:
Collaborator:
Texas A&M University
Information provided by (Responsible Party):
University of Arizona

Brief Summary:

Folklore has suggested that consuming grapefruit may promote weight control. Sparse data exist to support this hypothesis, though there is some evidence of health promotional effects regarding blood pressure and lipid profiles. The aims of this randomized controlled trial are to determine the role of grapefruit in:

  1. Reducing weight
  2. Reducing blood pressure
  3. Reducing inflammation
  4. Improving the lipid profile.

The investigators hypothesize that six weeks of daily consumption of grapefruit will reduce weight, blood pressure, and inflammation while improving the lipid profile in overweight, healthy adults.


Condition or disease Intervention/treatment Phase
Weight Loss Obesity Cardiovascular Risk Factors Other: Grapefruit Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficiency of Daily Grapefruit Exposure in Reducing Body Weight and Inflammatory Markers
Study Start Date : August 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Grapefruit Consumption Other: Grapefruit
1.5 Rio Red Grapefruit consumed daily for 6 weeks

Active Comparator: Control Other: Control
Participants followed a diet low in bioactive rich fruits and vegetables and avoided citrus for six weeks




Primary Outcome Measures :
  1. Weight reduction [ Time Frame: 6 weeks ]
    Participants consumed 1/2 grapefruit before each meal (1.5 grapefruit per day) for six weeks. Weight was measured before and after grapefruit consumption to assess weight change. Weight change was considered statistically significant at p<0.05.


Secondary Outcome Measures :
  1. Blood pressure reduction [ Time Frame: 6 weeks ]
    Previous studies in animals and humans consuming citrus have resulted in reductions in blood pressure, though no direct effect of grapefruit has ever been demonstrated. Blood pressure was measured at baseline and after the 6 week intervention period (consuming either the control diet or supplementing the diet with 1/2 grapefruit before each meal).

  2. Lipid Profile Improvements [ Time Frame: 6 weeks ]
    Previous studies in humans and animal models consuming grapefruit or grapefruit bioactives have shown reductions in triglycerides, LDL, and total cholesterol and increases in circulating HDL. These parameters were measured via a common point-of-care system, LDX Cholestech. Lipids were measured at baseline and after the 6 week intervention period (consuming either the control diet or supplementing the diet with 1/2 grapefruit before each meal).

  3. Reductions in markers of chronic inflammation [ Time Frame: 6 weeks ]
    Markers of chronic inflammation, which are also associated with endothelial dysfunction and heart disease, like tumor necrosis factor alpha (TNFalpha), interleukin-1beta (IL-1beta), and soluble vascular cellular adhesion molecule-1 (sV-CAM1) were measured. Inflammatory markers were measured at baseline and after the 6 week intervention period (consuming either the control diet or supplementing the diet with 1/2 grapefruit before each meal).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults, men and premenopausal women
  • BMI: 25-45 kg/m2
  • Willing to maintain current exercise regimen (not to exceed 10 hours/week)
  • Willing to follow a diet low in bioactive rich fruits and vegetables and with no citrus

Exclusion Criteria:

  • History of chronic disease
  • Metabolic disease
  • Inflammatory disease
  • High cholesterol (>225 mg/dL)
  • Smoker
  • Taking medications metabolized by the Cytochrome P450 3A enzyme
  • History of alcohol or drug abuse

Information from the National Library of Medicine

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): NCT01452841


Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85721
Sponsors and Collaborators
University of Arizona
Texas A&M University
Investigators
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Principal Investigator: Cynthia Thomson, PhD, RD University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01452841     History of Changes
Other Study ID Numbers: 09-0695-02
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2011

Keywords provided by University of Arizona:
grapefruit
weight loss
blood pressure
lipids
inflammation

Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms