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| Tracking Information | |||||
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| First Received Date ICMJE | December 17, 2007 | ||||
| Last Updated Date | December 12, 2008 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00581074 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
metabolic syndrome [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Grapefruit or Grapefruit Juice on Anthropometry, Dietary Intakes, Appetite, and Metabolic Profile in Overweight and Obese Young and Middle-Aged Adults | ||||
| Official Title ICMJE | Effects of Grapefruit or Grapefruit Juice on Anthropometry, Dietary Intakes, Appetite, and Metabolic Profile in Overweight and Obese Young and Middle-Aged Adults | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Health Services Research, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Behavioral: diet (grapefruit or grapefruit juice) | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 90 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00581074 | ||||
| Responsible Party | Heidi J. Silver, State of Florida Dept of Citrus | ||||
| Study ID Numbers ICMJE | 060035 | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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