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Effects of Grapefruit or Grapefruit Juice on Anthropometry, Dietary Intakes, Appetite, and Metabolic Profile in Overweight and Obese Young and Middle-Aged Adults (GJW)

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00581074
First received: December 17, 2007
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
  Purpose

This trial examines the effects of grapefruit or grapefruit juice on anthropometry, dietary intakes, appetite, and metabolic profile in overweight and obese young and middle-aged adults.


Condition Intervention
Obesity
 Behavioral: diet (grapefruit or grapefruit juice)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Effects of Grapefruit or Grapefruit Juice on Anthropometry, Dietary Intakes, Appetite, and Metabolic Profile in Overweight and Obese Young and Middle-Aged Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • metabolic syndrome [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: G
grapefruit
 Behavioral: diet (grapefruit or grapefruit juice)
weight loss diet
Active Comparator: J
Juice
 Behavioral: diet (grapefruit or grapefruit juice)
weight loss diet
Placebo Comparator: W
placebo
 Behavioral: diet (grapefruit or grapefruit juice)
weight loss diet

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 30-39.9

Exclusion Criteria:

  • Pregnant or lactating
  • On medications that are interfered with by consuming grapefruit juice
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581074

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Heidi J Silver, PhD Vanderbilt University
  More Information

No publications provided

Responsible Party: Heidi J. Silver, State of Florida Dept of Citrus
ClinicalTrials.gov Identifier: NCT00581074     History of Changes
Other Study ID Numbers: 060035
Study First Received: December 17, 2007
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
obesity
diet
weight loss
metabolic syndrome

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013