A Grapefruit Feeding Trial in Healthy, Overweight Adults

NCT ID: NCT01452841

Last Updated: 2011-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-04-30

Brief Summary

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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

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Conditions

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Weight Loss Obesity Cardiovascular Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Grapefruit Consumption

Group Type EXPERIMENTAL

Grapefruit

Intervention Type OTHER

1.5 Rio Red Grapefruit consumed daily for 6 weeks

Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Participants followed a diet low in bioactive rich fruits and vegetables and avoided citrus for six weeks

Interventions

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Grapefruit

1.5 Rio Red Grapefruit consumed daily for 6 weeks

Intervention Type OTHER

Control

Participants followed a diet low in bioactive rich fruits and vegetables and avoided citrus for six weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas A&M University

OTHER

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia Thomson, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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09-0695-02

Identifier Type: -

Identifier Source: org_study_id