NCT02125955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

April 25, 2014

Last Update Submit

October 24, 2017

Conditions

OverweightObesity

Keywords

PediatricOverweightObesityGut microbiotaAdiposityPrebioticDietary fiber

Outcome Measures

Primary Outcomes (1)

  • Body fat

    Change in baseline fat mass at 16 weeks. Measured by dual energy x-ray absorptiometry.

    16 weeks

Secondary Outcomes (1)

  • Appetite regulation

    16 weeks

Other Outcomes (4)

  • Gut microbiota

    16 weeks

  • Serum lipids

    16 weeks

  • Serum glucose and insulin

    16 weeks

  • +1 more other outcomes

Study Arms (2)

Prebiotic fiber

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Prebiotic fiberDIETARY_SUPPLEMENT

Dissolved in water.

Also known as: Synergy 1 (oligofructose enriched inulin)
Prebiotic fiber
PlaceboDIETARY_SUPPLEMENT

Dissolved in water

Also known as: Maltodextrin
Placebo

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 28596023RESULT

  • 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.

    PMID: 28228425RESULT

MeSH Terms

Conditions

OverweightObesity

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Raylene A Reimer, PhD, RD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 29, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

September 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

CA(1)