A Grapefruit Feeding Trial in Healthy, Overweight Adults

Obesity Clinical Trial

Official title:

Efficiency of Daily Grapefruit Exposure in Reducing Body Weight and Inflammatory Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452841
• Other study ID #: 09-0695-02
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: October 14, 2011
• Start date: August 2009
• Est. completion date: April 2011

Study information

• Verified date: October 2011
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Risk Factors
• Obesity
• Weight Loss

Intervention

Other:
• Grapefruit
1.5 Rio Red Grapefruit consumed daily for 6 weeks
• Control
Participants followed a diet low in bioactive rich fruits and vegetables and avoided citrus for six weeks

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Blood pressure reduction	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).	6 weeks	No
Secondary	Lipid Profile Improvements	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).	6 weeks	No
Secondary	Reductions in markers of chronic inflammation	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).	6 weeks	No