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OpenTrials
Completed

NCT Number: NCT02125955

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

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Boys and girls between the ages of 7-12 years old
  • BMI percentiles >85th percentile for their age and sex
  • Tanner stage of ≤ 3, girls premenarche

Exclusion criteria

  • Tanner stage of >3 or girls postmenarchal
  • Use of antibiotics up to 3 months prior to study
  • Regular prebiotic supplement and/or probiotic supplement use
  • Subjects unable to provide consent (parental) or assent (child)

Treatment and study plan

Prebiotic fiber

Dietary Supplement

Dissolved in water.

Other names: Synergy 1 (oligofructose enriched inulin)

Placebo

Dietary Supplement

Dissolved in water

Other names: Maltodextrin

Primary outcomes

  1. Body fat

    Time frame: 16 weeks

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

Secondary outcomes

  1. Appetite regulation

    Time frame: 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 outcomes

  1. Gut microbiota

    Time frame: 16 weeks

    Change in baseline gut microbiota at 16 weeks.

  2. Serum lipids

    Time frame: 16 weeks

    Change in baseline serum lipids at 16 weeks.

  3. Serum glucose and insulin

    Time frame: 16 weeks

    Change in baseline glucose and insulin at 16 weeks.

  4. Inflammatory markers

    Time frame: 16 weeks

    Change in serum inflammatory markers at 16 weeks.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Children's Hospital

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2017
First posted
Apr 29, 2014
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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