A Grapefruit Feeding Trial in Healthy, Overweight Adults
|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: NCT01452841|
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : October 17, 2011
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:
- Reducing weight
- Reducing blood pressure
- Reducing inflammation
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Grapefruit Consumption||
1.5 Rio Red Grapefruit consumed daily for 6 weeks
|Active Comparator: Control||
Participants followed a diet low in bioactive rich fruits and vegetables and avoided citrus for six weeks
- 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.
- 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).
- 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).
- 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).
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
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85721|
|Principal Investigator:||Cynthia Thomson, PhD, RD||University of Arizona|