Low Glycemic Load Diets in Latino Children at Risk for Type 2 Diabetes
COOL Kids
COOL Kids
Sponsor study identifier
Secondary identifiers
NIH
interventional
113
1 country
1
Study Start
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)The purpose of this study are to:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
February 11, 2010
Actual (reported)February 12, 2010
Actual (reported)May 2010
Actual (reported)May 2010
Actual (reported)Change in insulin sensitivity between the two dietary arms
at 3-, 12- and 24 months
Change in BMI z-score between the two dietary groups
3-, 12-, and 24 months
Change in body fat mass, lipid assay (LDL cholesterol, TG, FFA) between the two dietary arms
3-, 12-, and 24 months
Differences in subjective, hormonal, and metabolic between the two dietary arms
3 months
The subjects and their parents will be given instructions, and specific examples, to lower the glycemic load of their diets by replacing high-GI sources of carbohydrates with low-GI food sources, replacing energy from carbohydrate with energy from protein and fat, and attempt to balance meals and snacks with low-GI carbohydrate, proteins and low-fat food sources. The objective will be to achieve macronutrient composition for the low-GL diet of 45-50% low-GI carbohydrates, 20-25% protein, and 30-35% fat. All subjects will receive sessions on behavior modification, increasing physical activity and reducing sedentary behavior. At 3 months, subjects will be admitted to the GCRC for a 24 hour period for a meal study. They will be given standardized low-glycemic load diet for dinner, breakfast and lunch, followed by an ad lib snack platter. Their subjective, hormonal and metabolic responses will be serially measured.
For the low fat diet, subjects and their parents will be given instructions, and specific examples, to lower the fat content of their diet. The composition of the low-fat diet will be targeted to achieve 55-60% carbohydrates (with no discrimination by their glycemic index), 15-20% protein and 25-30% fat. All recruited children will receive sessions on behavior modification, increasing physical activity and reducing sedentary behavior. At 3 months, subjects will be admitted to the GCRC for a 24 hour period for a meal study. They will be given standardized high-glycemic load diet for dinner, breakfast and lunch, followed by an ad lib snack platter. Their subjective, hormonal and metabolic responses will be serially measured.
We propose a randomized controlled clinical trial to evaluate the effectiveness of a low-glycemic load diet versus low-fat diet on insulin sensitivity, body composition, and other hormonal and biochemical measures. The culturally competent and family-based Intervention program has a dietary experimental component (low-glycemic load versus low-fat diet), as well as elements of physical activity, reduction in sedentary behavior and behavior modification. The nutrition training sessions are divided into 12 modules taught over a 12-week course. Care has been taken to make the content and intensity of the low-fat and low-glycemic load programs comparable. Both treatments include 12 weekly sessions, followed by nine monthly, and four 3-monthly sessions. Participants are obese (BMI ≥95th percentile for age and sex) Hispanic American children ages 7-14 years.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Mirza NM, Palmer MG, Sinclair KB, McCarter R, He J, Ebbeling CB, Ludwig DS, Yanovski JA. Effects of a low glycemic load or a low-fat dietary intervention on body weight in obese Hispanic American children and adolescents: a randomized controlled trial. Am J Clin Nutr. 2013 Feb;97(2):276-85. doi: 10.3945/ajcn.112.042630. Epub 2012 Dec 19.
Mirza NM, Klein CJ, Palmer MG, McCarter R, He J, Ebbeling CB, Ludwig DS, Yanovski JA. Effects of high and low glycemic load meals on energy intake, satiety and hunger in obese Hispanic-American youth. Int J Pediatr Obes. 2011 Jun;6(2-2):e523-31. doi: 10.3109/17477166.2010.544740. Epub 2011 Feb 10.
Nazrat M Mirza, MD, ScD
Children's National Research Institute
113 participants (actual enrollment reported by the registry).
First Submitted
February 11, 2010
First Posted
February 12, 2010
Study Start
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
Glaser Obesity Study
Contact the study team to confirm eligibility.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)Last Updated
September 9, 2014
Record last verified: 2014-09
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