Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prebiotic fiber
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring Pediatric, Overweight, Obesity, Gut microbiota, Adiposity, Prebiotic, Dietary fiber
Eligibility Criteria
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)
Sites / Locations
- University of Calgary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Prebiotic fiber
Placebo
Arm Description
The intervention group will consume an 8 gram dose of prebiotic fiber one time per day approximately 30 minutes prior to their evening meal.
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.
Outcomes
Primary Outcome Measures
Body fat
Change in baseline fat mass at 16 weeks. Measured by dual energy x-ray absorptiometry.
Secondary Outcome Measures
Appetite regulation
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.
Full Information
NCT ID
NCT02125955
First Posted
April 25, 2014
Last Updated
October 24, 2017
Sponsor
University of Calgary
Collaborators
Alberta Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02125955
Brief Title
Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children
Official Title
Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Pediatric, Overweight, Obesity, Gut microbiota, Adiposity, Prebiotic, Dietary fiber
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prebiotic fiber
Arm Type
Experimental
Arm Description
The intervention group will consume an 8 gram dose of prebiotic fiber one time per day approximately 30 minutes prior to their evening meal.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic fiber
Other Intervention Name(s)
Synergy 1 (oligofructose enriched inulin)
Intervention Description
Dissolved in water.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Maltodextrin
Intervention Description
Dissolved in water
Primary Outcome Measure Information:
Title
Body fat
Description
Change in baseline fat mass at 16 weeks. Measured by dual energy x-ray absorptiometry.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Appetite regulation
Description
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.
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Gut microbiota
Description
Change in baseline gut microbiota at 16 weeks.
Time Frame
16 weeks
Title
Serum lipids
Description
Change in baseline serum lipids at 16 weeks.
Time Frame
16 weeks
Title
Serum glucose and insulin
Description
Change in baseline glucose and insulin at 16 weeks.
Time Frame
16 weeks
Title
Inflammatory markers
Description
Change in serum inflammatory markers at 16 weeks.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raylene A Reimer, PhD, RD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28596023
Citation
Nicolucci AC, Hume MP, Martinez I, Mayengbam S, Walter J, Reimer RA. Prebiotics Reduce Body Fat and Alter Intestinal Microbiota in Children Who Are Overweight or With Obesity. Gastroenterology. 2017 Sep;153(3):711-722. doi: 10.1053/j.gastro.2017.05.055. Epub 2017 Jun 5.
Results Reference
result
PubMed Identifier
28228425
Citation
Hume MP, Nicolucci AC, Reimer RA. Prebiotic supplementation improves appetite control in children with overweight and obesity: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):790-799. doi: 10.3945/ajcn.116.140947. Epub 2017 Feb 22.
Results Reference
result
Learn more about this trial
Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children
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