Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01255228
First received: November 18, 2010
Last updated: December 5, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention
Obesity
Other: Low glycemic index diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • the effect of body composition ( body weight,body mass,waist and hip circumferences ) [ Time Frame: 6 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low glycemic index diet
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
Other: 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: diet intervention
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
Other: Low glycemic index diet
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255228

Locations
Taiwan
Taipei Medical University
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Jen-Fang Liu Taipei Medical University
  More Information

No publications provided

Responsible Party: Jen-Fang Liu, Taipei Medical University, School of Nutrition and Health Sciences
ClinicalTrials.gov Identifier: NCT01255228     History of Changes
Other Study ID Numbers: 99055
Study First Received: November 18, 2010
Last Updated: December 5, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
obesity
body composition
adipocyte-derived cytokine
low glycemic index

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

ClinicalTrials.gov processed this record on September 16, 2014