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

October 24, 2017 updated by: Dr. Raylene Reimer, University of Calgary
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat
Time Frame: 16 weeks
Change in baseline fat mass at 16 weeks. Measured by dual energy x-ray absorptiometry.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota
Time Frame: 16 weeks
Change in baseline gut microbiota at 16 weeks.
16 weeks
Serum lipids
Time Frame: 16 weeks
Change in baseline serum lipids at 16 weeks.
16 weeks
Serum glucose and insulin
Time Frame: 16 weeks
Change in baseline glucose and insulin at 16 weeks.
16 weeks
Inflammatory markers
Time Frame: 16 weeks
Change in serum inflammatory markers at 16 weeks.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Alberta Children's Hospital

Investigators

  • Principal Investigator: Raylene A Reimer, PhD, RD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-1026386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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