A Grapefruit Feeding Trial in Healthy, Overweight Adults

Not Applicable

Completed

• Conditions: Obesity; Cardiovascular Risk Factors; Weight Loss
• Interventions: Other: Grapefruit; Other: Control

• Registration Number: NCT01452841
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-07-21
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-14
• Last Update Submitted: 2011-10-14
• Study First Posted: 2011-10-17
• Last Update Posted: 2011-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Grapefruit Consumption	Grapefruit	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Weight reduction	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

Name	Time	Method
Reductions in markers of chronic inflammation	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).
Blood pressure reduction	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	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).

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States