Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT02125955

Collaborator

Alberta Children's Hospital (Other)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Currently, over one third of Canadian children and youth aged five to seventeen are overweight or obese. Childhood obesity leads to increased risks of co-morbidities such as type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers. Changes in the food supply have been linked to obesity and include a decrease in the intake of dietary fiber. Prebiotic fibers are a group of non-digestible carbohydrates that modulate the composition and actions of the gut microbiota and have been shown to reduce body fat and energy intake in overweight and obese adults. The investigators hypothesis is that prebiotic fiber intake in overweight and obese children will similarly result in improvements in body composition and reduced energy intake.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity	Dietary Supplement: Prebiotic fiber Dietary Supplement: Placebo	N/A

Detailed Description

Obesity in the pediatric population is a primary public health concern given that overweight and obesity in childhood continues into adulthood. Consumption of high-fat, calorie-dense diets do not provide individuals with the suggested daily intake of many important nutrients. This is especially true for dietary fiber which has positive health benefits such as roles in weight management. A form of dietary fiber with links to obesity treatment/prevention is prebiotic fiber. In the gut, there are many bacteria which have been shown to affect a person's health depending on the type and number of each type of bacteria. The role of prebiotic fiber is to increase the number of beneficial bacteria which in turn promotes health. Studies in humans have shown that prebiotic fiber is effective at reducing body fat and food intake in overweight and obese adults. The aim of this study is to see if prebiotic fiber can provide the same benefits to overweight and obese children. Since weight management becomes increasingly difficult as a person ages, treatments that promote weight maintenance at an early age are critically needed.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children

Actual Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prebiotic fiber The intervention group will consume an 8 gram dose of prebiotic fiber one time per day approximately 30 minutes prior to their evening meal.	Dietary Supplement: Prebiotic fiber Dissolved in water. Other Names: Synergy 1 (oligofructose enriched inulin)
Placebo Comparator: Placebo The placebo group will consume an isocaloric dose of placebo (maltodextrin; 3.3 grams) one time per day approximately 30 minutes prior to their evening meal.	Dietary Supplement: Placebo Dissolved in water Other Names: Maltodextrin

Arm

Intervention/Treatment

Experimental: Prebiotic fiber

The intervention group will consume an 8 gram dose of prebiotic fiber one time per day approximately 30 minutes prior to their evening meal.

Dietary Supplement: Prebiotic fiber

Dissolved in water.

Other Names:

Synergy 1 (oligofructose enriched inulin)

Placebo Comparator: Placebo

The placebo group will consume an isocaloric dose of placebo (maltodextrin; 3.3 grams) one time per day approximately 30 minutes prior to their evening meal.

Dietary Supplement: Placebo

Dissolved in water

Other Names:

Maltodextrin

Outcome Measures

Primary Outcome Measures

Body fat [16 weeks]
Change in baseline fat mass at 16 weeks. Measured by dual energy x-ray absorptiometry.

Secondary Outcome Measures

Appetite regulation [16 weeks]
Change in baseline appetite at 16 weeks. Subjective appetite assessed with visual analog scales and eating behavior questionnaire. Objective measures include a weighed breakfast buffet, weighted 3-day food records and serum satiety hormone levels.

Other Outcome Measures

Gut microbiota [16 weeks]
Change in baseline gut microbiota at 16 weeks.
Serum lipids [16 weeks]
Change in baseline serum lipids at 16 weeks.
Serum glucose and insulin [16 weeks]
Change in baseline glucose and insulin at 16 weeks.
Inflammatory markers [16 weeks]
Change in serum inflammatory markers at 16 weeks.