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Completed

NCT Number: NCT01452841

A Grapefruit Feeding Trial in Healthy, Overweight Adults

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Cardiovascular Risk Factors Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grapefruit

Other

1.5 Rio Red Grapefruit consumed daily for 6 weeks

Control

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Texas A&M University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 17, 2011
Registry last updated
Oct 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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