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

NCT ID: NCT01255228

Last Updated: 2010-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

obesity body composition adipocyte-derived cytokine low glycemic index

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low glycemic index diet

The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women

Group Type EXPERIMENTAL

Low glycemic index diet

Intervention Type OTHER

The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women

diet intervention

The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women

Group Type EXPERIMENTAL

Low glycemic index diet

Intervention Type OTHER

The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low glycemic index diet

The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Taipei Medical University, School of Nutrition and Health Sciences

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jen-Fang Liu

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Medical University

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

99055

Identifier Type: -

Identifier Source: org_study_id