Recruitment

Recruitment Status
Completed
Estimated Enrollment
44

Inclusion Criteria

Tanner stage of ≤ 3, girls premenarche
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
Boys and girls between the ages of 7-12 years old
BMI percentiles >85th percentile for their age and sex

Exclusion Criteria

Use of antibiotics up to 3 months prior to study
Tanner stage of >3 or girls postmenarchal
Subjects unable to provide consent (parental) or assent (child)
...
Use of antibiotics up to 3 months prior to study
Tanner stage of >3 or girls postmenarchal
Subjects unable to provide consent (parental) or assent (child)
Regular prebiotic supplement and/or probiotic supplement use

Summary

Conditions
  • Obesity
  • Overweight
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 7 years and 12 years
Gender
Both males and females

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...

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.

Inclusion Criteria

Tanner stage of ≤ 3, girls premenarche
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
Boys and girls between the ages of 7-12 years old
BMI percentiles >85th percentile for their age and sex

Exclusion Criteria

Use of antibiotics up to 3 months prior to study
Tanner stage of >3 or girls postmenarchal
Subjects unable to provide consent (parental) or assent (child)
...
Use of antibiotics up to 3 months prior to study
Tanner stage of >3 or girls postmenarchal
Subjects unable to provide consent (parental) or assent (child)
Regular prebiotic supplement and/or probiotic supplement use

Tracking Information

NCT #
NCT02125955
Collaborators
Alberta Children's Hospital
Investigators
  • Principal Investigator: Raylene A Reimer, PhD, RD University of Calgary
  • Raylene A Reimer, PhD, RD University of Calgary