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

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ClinicalTrials.gov Identifier: NCT02125955
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Alberta Children's Hospital
Information provided by (Responsible Party):
Dr. Raylene Reimer, University of Calgary

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 Not Applicable

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  (Clinical Trial)
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 : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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 Name: 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 Name: Maltodextrin




Primary Outcome Measures :
  1. Body fat [ Time Frame: 16 weeks ]
    Change in baseline fat mass at 16 weeks. Measured by dual energy x-ray absorptiometry.


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125955


Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Alberta Children's Hospital
Investigators
Principal Investigator: Raylene A Reimer, PhD, RD University of Calgary

Publications of Results:
Responsible Party: Dr. Raylene Reimer, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02125955     History of Changes
Other Study ID Numbers: UC-1026386
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Dr. Raylene Reimer, University of Calgary:
Pediatric
Overweight
Obesity
Gut microbiota
Adiposity
Prebiotic
Dietary fiber

Additional relevant MeSH terms:
Overweight
Obesity
Body Weight
Signs and Symptoms
Overnutrition
Nutrition Disorders