Overview

This trial is active, not recruiting.

Condition obesity
Treatment low glycemic index diet
Sponsor Taipei Medical University WanFang Hospital
Start date May 2010
End date February 2011
Trial size 20 participants
Trial identifier NCT01255228, 99055

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
low glycemic index diet
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
(Experimental)
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
low glycemic index diet
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women

Primary Outcomes

Measure
the effect of body composition ( body weight,body mass,waist and hip circumferences )
time frame: 6 week

Eligibility Criteria

Female participants from 20 years up to 50 years old.

Inclusion Criteria: - BMI above 24 kg/m2, or the either one ( fat mass ≧ 30% or waistline > 80 cm ) Exclusion Criteria: - 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

Additional Information

Official title Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese
Principal investigator Jen-Fang Liu
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by Taipei Medical University WanFang Hospital.