A Grapefruit Feeding Trial in Healthy, Overweight Adults
Efficiency of Daily Grapefruit Exposure in Reducing Body Weight and Inflammatory Markers
1 other identifier
interventional
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedOctober 17, 2011
October 1, 2011
1.7 years
July 21, 2011
October 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight reduction
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.
6 weeks
Secondary Outcomes (3)
Blood pressure reduction
6 weeks
Lipid Profile Improvements
6 weeks
Reductions in markers of chronic inflammation
6 weeks
Study Arms (2)
Grapefruit Consumption
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Participants followed a diet low in bioactive rich fruits and vegetables and avoided citrus for six weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- Texas A&M Universitycollaborator
Study Sites (1)
University of Arizona
Tucson, Arizona, 85721, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Thomson, PhD, RD
University of Arizona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2011
First Posted
October 17, 2011
Study Start
August 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
October 17, 2011
Record last verified: 2011-10