Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children
|ClinicalTrials.gov Identifier: NCT02125955|
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Dietary Supplement: Prebiotic fiber Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- Body fat [ Time Frame: 16 weeks ]Change in baseline fat mass at 16 weeks. Measured by dual energy x-ray absorptiometry.
- 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.
- Gut microbiota [ Time Frame: 16 weeks ]Change in baseline gut microbiota at 16 weeks.
- Serum lipids [ Time Frame: 16 weeks ]Change in baseline serum lipids at 16 weeks.
- Serum glucose and insulin [ Time Frame: 16 weeks ]Change in baseline glucose and insulin at 16 weeks.
- Inflammatory markers [ Time Frame: 16 weeks ]Change in serum inflammatory markers at 16 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125955
|University of Calgary|
|Calgary, Alberta, Canada, T2N 1N4|
|Principal Investigator:||Raylene A Reimer, PhD, RD||University of Calgary|