Effect of Glycemic Load on Body Composition

Obesity Clinical Trial

Official title:

Assessment of Glycemic Load on Body Composition Among Overweight and Obese Adults During 12 Month Period

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00603655
• Other study ID #: UABC4268
• Secondary ID: UABC20074268
• Status: Terminated
• Phase: Phase 0
• First received: January 16, 2008
• Last updated: December 30, 2008
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: Universidad Autonoma de Baja California
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Overweight or obese adults

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Low glycemic load diet
Low glycemic load diet
• High glycemic load diet
High glycemic load diet

Locations

Country	Name	City	State
Mexico	Facultad de Medicina y Psicología	Tijuana	Baja California

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Baja California

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of body fat percentage		3, 6, 9 and 12 months	No
Secondary	Reduction of homeostasis model assessment (HOMA)		3, 6, 9 and 12 months	No