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Effect of Glycemic Load on Body Composition

Primary Purpose

Overweight, Obesity

Status
Terminated
Phase
Early Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Low glycemic load diet
High glycemic load diet
Sponsored by
Universidad Autonoma de Baja California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring Diet, glycemic load, overweight, obesity, hyperlipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Overweight or obese adults

Exclusion Criteria:

  • Subjects who are pregnant or have diabetes, cancer, psychiatric disorders or physical disabilities

Sites / Locations

  • Facultad de Medicina y Psicología

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

This group will receive a low glycemic load

This group will receive a high glycemic load

Outcomes

Primary Outcome Measures

Reduction of body fat percentage

Secondary Outcome Measures

Reduction of homeostasis model assessment (HOMA)

Full Information

First Posted
January 16, 2008
Last Updated
December 30, 2008
Sponsor
Universidad Autonoma de Baja California
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1. Study Identification

Unique Protocol Identification Number
NCT00603655
Brief Title
Effect of Glycemic Load on Body Composition
Official Title
Assessment of Glycemic Load on Body Composition Among Overweight and Obese Adults During 12 Month Period
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Terminated
Why Stopped
Higher drop out than expected. Lower Statistical Power.
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad Autonoma de Baja California

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to compare the effects of diets with different glycemic load (GL) on body composition and biochemical markers in overweight and obese subjects during a 12-month period.
Detailed Description
Study Procedure: The study is a randomized, experimental, parallel design conducted in a group of Mexican subjects during a 6-month period. Anthropometric and biochemical data will be determined at 0, 3, 6, 9 and 12 months. Subjects: Overweight or obese adults were assigned into two groups: LGL diet and HGL diet. Subjects who were pregnant or had diabetes, cancer, psychiatric disorders or physical disabilities were excluded. Diets and Dietary Assessment: Two diets were designed including LGL and HGL diets. GI values of each food were estimated from the tables by Foster-Powell et al. Daily GL was determined by the product of total dietary carbohydrate (grams) and GI of each food and adjusted to energetic intake using the following formulas: GI = Σ (GI of each food X proportion of total carbohydrate contributed from each food); GL= Σ (GI of each food × grams of total carbohydrate from each food)/1000 kcal. Diets were designed according to the food habits of Mexicans living in the Tijuana area. On the first day, subjects received different menus of either LGL or HGL diets, according to the randomization. A research assistant was available by mail or by phone for questions during the 6-month period. An e-mail, as a reminder and reinforcement to maintain the diet, was sent every 2 weeks to all participants. Subjects who completed the 3-day dietary record (two weekdays and one weekend day) were included in the analysis. Anthropometric Measurements: Height was measured to the nearest millimeter using a portable stadiometer (model 214 Road Rod, Seca Corp., Hanover, MD). Weight was measured to the nearest 0.1 kg using an electronic scale (Bod Pod, Life Measurement Inc., Concord, CA). Subjects were dressed in light clothing and were not wearing shoes. Body mass index (BMI) was calculated using the following formula: weight (kg)/height (m2). Waist circumference (WC) was measured at the minimum circumference between the iliac crest and the rib cage. Fat mass (in kg) and total body fat percentage were measured by plethysmography with the Bod Pod. The subjects entered the Bod Pod wearing a bodysuit and Lycra hat. Blood Analysis: Venous blood samples were taken at 8 AM from an antecubital vein after a 12-hour overnight fast, again at baseline and at 3 months after beginning the study. Blood samples were centrifuged at 3500 × g for 3 minutes, and plasma was removed and analyzed immediately after collection. For quantitative determination of glucose in serum, the glucose oxidase procedure based on a modified Trinder method was used (SERA-PAK Plus, Bayer, Sées, France). Serum insulin levels were determined by chemiluminescent immunoassay by the IMMULITE 2000 analyzer (Diagnostic Products Corporation, Los Angeles, CA). Homeostasis model assessment (HOMA) was used to estimate insulin resistance and was computed as follows: (fasting serum insulin [μU/ml] × fasting plasma glucose [mmol/L]/22.5). Total cholesterol, HDL-cholesterol and triglycerides were measured by enzymatic methods (SERA-PAK Plus); LDL-cholesterol was calculated using the Friedwald formula: LDL (mmol/L) = total cholesterol - (TG/2.2) - HDL. Physical Activity Assessment: A questionnaire containing seven questions from the International Physical Activity Questionnaire (IPAQ) was used to evaluate physical activity at baseline and at 1, 3 and 6 months after study initiation. Statistical Analysis: Mean ± standard deviations were calculated using descriptive statistics in all variables. Anthropometric measurements were evaluated, and it was determined that they did not meet the normality test (Kolmogorov-Smirnov and Shapiro-Wilk). To test differences between groups on biochemical and anthropometric measurements, Mann-Whitney non-parametric test for independent samples was performed. For comparison of differences before, at 3 and 6 months after intervention in the same treatment group, we used Friedman non-parametric test for repeated measurements. To test differences between groups on diet intake at baseline and at the end of the study, Mann-Whitney non-parametric test for independent samples was performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Diet, glycemic load, overweight, obesity, hyperlipidemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
This group will receive a low glycemic load
Arm Title
B
Arm Type
Active Comparator
Arm Description
This group will receive a high glycemic load
Intervention Type
Other
Intervention Name(s)
Low glycemic load diet
Other Intervention Name(s)
Low glycemic index
Intervention Description
Low glycemic load diet
Intervention Type
Other
Intervention Name(s)
High glycemic load diet
Intervention Description
High glycemic load diet
Primary Outcome Measure Information:
Title
Reduction of body fat percentage
Time Frame
3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Reduction of homeostasis model assessment (HOMA)
Time Frame
3, 6, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Overweight or obese adults Exclusion Criteria: Subjects who are pregnant or have diabetes, cancer, psychiatric disorders or physical disabilities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Jimenez-Cruz, MD
Organizational Affiliation
Universidad Autonoma de Baja California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Medicina y Psicología
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22390
Country
Mexico

12. IPD Sharing Statement

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Effect of Glycemic Load on Body Composition

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