Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women
1 other identifier
interventional
20
1 country
1
Brief Summary
Excessive body weight and obesity have reached epidemic proportions over the last few decades, which may cause many chronic diseases. Maintaining a healthy life style could decrease the risk for obesity, metabolic syndrome and cardiovascular disease. The study aimed to evaluate long-term low glycemic index (GI) diet intervention on lipid profile, body composition and the mechanism of obese women. The pilot study will recruit twenty healthy subjects, and served test food to determine low GI food. In the experiment period, twenty women age from 20-50 years will be recruited. To be included in the study, subjects should have a BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline \> 80 cm). Before dietary intervention, participants will receive food choice table and dietary questionnaires to record their dietary intake. The study will be a randomized, crossover, controlled clinical trails. The experiment period have six weeks, each participants will provide low GI diet (lunch and dinner). On the 0, 3, 6 week, subjects will measurement their body composition (body weight, body mass, waist and hip circumferences) and collect fasting blood samples to analysis the lipid profile, free fatty acid, blood sugar, insulin, adiponectin, leptin and fatty acid synthesis enzymes. Statistical analysis will be performed by paired t-test. The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started May 2010
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 18, 2010
CompletedFirst Posted
Study publicly available on registry
December 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedDecember 7, 2010
December 1, 2010
9 months
November 18, 2010
December 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the effect of body composition ( body weight,body mass,waist and hip circumferences )
6 week
Study Arms (2)
Low glycemic index diet
EXPERIMENTALThe study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
diet intervention
EXPERIMENTALThe study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
Interventions
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
Eligibility Criteria
You may qualify if:
- BMI above 24 kg/m2, or the either one ( fat mass ≧ 30% or waistline \> 80 cm )
You may not qualify if:
- Cardiovascular disease
- type 2 diabetes mellitus or impaired glucose tolerance
- serious liver or renal disease, gastro-intestinal disease
- proceed serious diet control for formerly three months
- take any supplemental food products or medications known to influence lipid or carbohydrate metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jen-Fang Liu
Taipei Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 18, 2010
First Posted
December 7, 2010
Study Start
May 1, 2010
Primary Completion
February 1, 2011
Study Completion
April 1, 2011
Last Updated
December 7, 2010
Record last verified: 2010-12