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A Grapefruit Feeding Trial in Healthy, Overweight Adults

Primary Purpose

Weight Loss, Obesity, Cardiovascular Risk Factors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Grapefruit
Control
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss focused on measuring grapefruit, weight loss, blood pressure, lipids, inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Grapefruit Consumption

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
July 21, 2011
Last Updated
October 14, 2011
Sponsor
University of Arizona
Collaborators
Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT01452841
Brief Title
A Grapefruit Feeding Trial in Healthy, Overweight Adults
Official Title
Efficiency of Daily Grapefruit Exposure in Reducing Body Weight and Inflammatory Markers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Texas A&M University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity, Cardiovascular Risk Factors
Keywords
grapefruit, weight loss, blood pressure, lipids, inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grapefruit Consumption
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Grapefruit
Intervention Description
1.5 Rio Red Grapefruit consumed daily for 6 weeks
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants followed a diet low in bioactive rich fruits and vegetables and avoided citrus for six weeks
Primary Outcome Measure Information:
Title
Weight reduction
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Blood pressure reduction
Description
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).
Time Frame
6 weeks
Title
Lipid Profile Improvements
Description
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).
Time Frame
6 weeks
Title
Reductions in markers of chronic inflammation
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Thomson, PhD, RD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States

12. IPD Sharing Statement

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A Grapefruit Feeding Trial in Healthy, Overweight Adults

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