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
|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.
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
|University of Calgary|
|Calgary, Alberta, Canada, T2N 1N4|
|Principal Investigator:||Raylene A Reimer, PhD, RD||University of Calgary|