Effects of Grapefruit or Grapefruit Juice on Anthropometry, Dietary Intakes, Appetite, and Metabolic Profile in Overweight and Obese Young and Middle-Aged Adults (GJW)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diet (grapefruit or grapefruit juice)
Sponsored by
About this trial
This is an interventional health services research trial for Obesity focused on measuring obesity, diet, weight loss, metabolic syndrome
Eligibility Criteria
Inclusion Criteria:
- BMI 30-39.9
Exclusion Criteria:
- Pregnant or lactating
- On medications that are interfered with by consuming grapefruit juice
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
G
J
W
Arm Description
grapefruit
Juice
placebo
Outcomes
Primary Outcome Measures
weight loss
Secondary Outcome Measures
metabolic syndrome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00581074
Brief Title
Effects of Grapefruit or Grapefruit Juice on Anthropometry, Dietary Intakes, Appetite, and Metabolic Profile in Overweight and Obese Young and Middle-Aged Adults
Acronym
GJW
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, diet, weight loss, metabolic syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
G
Arm Type
Active Comparator
Arm Description
grapefruit
Arm Title
J
Arm Type
Active Comparator
Arm Description
Juice
Arm Title
W
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Behavioral
Intervention Name(s)
diet (grapefruit or grapefruit juice)
Intervention Description
weight loss diet
Primary Outcome Measure Information:
Title
weight loss
Time Frame
3 months
Secondary Outcome Measure Information:
Title
metabolic syndrome
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI 30-39.9
Exclusion Criteria:
Pregnant or lactating
On medications that are interfered with by consuming grapefruit juice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi J Silver, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21288350
Citation
Silver HJ, Dietrich MS, Niswender KD. Effects of grapefruit, grapefruit juice and water preloads on energy balance, weight loss, body composition, and cardiometabolic risk in free-living obese adults. Nutr Metab (Lond). 2011 Feb 2;8(1):8. doi: 10.1186/1743-7075-8-8.
Results Reference
derived
Learn more about this trial
Effects of Grapefruit or Grapefruit Juice on Anthropometry, Dietary Intakes, Appetite, and Metabolic Profile in Overweight and Obese Young and Middle-Aged Adults
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