Combining Prebiotic and Diet/Physical Activity Educational Program Effects on Body Composition and Intestinal Microbiota in Children

NCT ID: NCT05671731

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-13
• Study Completion Date: 2013-04-11

Brief Summary

The purpose of this study was to determine the feasibility, acceptability, and initial efficacy of combining prebiotic (Beneo Synergy 1) and calcium treatment with Project FUN (an online nutrition and physical activity program) on body composition and intestinal microbiota among 4th and 5th grade children whose social determinants placed them at higher risk for obesity. This aim was addressed through testing the following hypotheses:

H1 Prebiotic and calcium supplementation in combination with Project FUN, will result in improved body composition scores, dietary fat percentage, and physical activity compared to a usual class control who did not receive the intervention.

H2 Higher counts of Bacteroides and Bifidobacterium as well as fewer Firmicutes in the stool samples will correlate with improvement in body composition scores.

Since this was a pilot community-based efficacy study, the following feasibility, acceptability, and descriptive research questions were also addressed:

RQ1 What percentages of participants submit stool samples, body composition assessments and complete at least 70 percent of the intervention over the course of a 12-week study? RQ2 What is the relationship between changes in body composition scores, dietary fat percentage, physical activity and microbiota in stool samples before and after the 12-week intervention?

Detailed Description

The purpose of this study was to determine the feasibility, acceptability, and initial efficacy of combining prebiotic (Beneo Synergy 1) and calcium treatment with Project FUN (an online nutrition and physical activity program) on body composition and intestinal microbiota among 4th and 5th grade children whose social determinants placed them at higher risk for obesity. This aim was addressed through testing the following hypotheses:

H1 Prebiotic and calcium supplementation in combination with Project FUN, will result in improved body composition scores, dietary fat percentage, and physical activity compared to a usual class control who did not receive the intervention.

H2 Higher counts of Bacteroides and Bifidobacterium as well as fewer Firmicutes in the stool samples will correlate with improvement in body composition scores.

Since this was a pilot community-based efficacy study, the following feasibility, acceptability, and descriptive research questions were also addressed:

RQ1 What percentages of participants submit stool samples, body composition assessments and complete at least 70 percent of the intervention over the course of a 12-week study? RQ2 What is the relationship between changes in body composition scores, dietary fat percentage, physical activity and microbiota in stool samples before and after the 12-week intervention? The sample included 4th- 5th grade students at two private urban schools where 98% were eligible for free or reduced fee lunch. Of the 123 consenting 56% were male; 71% Latinx; 15% African American; 14% Other. Three percent were underweight; 49% normal weight; 22% overweight; 25% obese.

Consenting Latinx (n=20) and African American (n=8) participants completed microbiome analysis. Of these 54% were male; 6.5% underweight; 38.7% normal weight; 32.3% overweight; 2.6% obese.

Conditions

Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

The intervention group received Beneo Synergy 1 - 4gm twice/school day in 4 ounces orange juice with calcium for 12 weeks. We started with 1gm then increased the next day by a gram to reach the 4gm dose.

Intervention group participants completed Project FUN (8 module online nutrition and physical activity program) individually (password protected) in the school computer lab along with a workbook also used to check intervention completion.

Group Type: EXPERIMENTAL

Beneo Synergy 1

Intervention Type: DIETARY_SUPPLEMENT

Project FUN

Intervention Type: BEHAVIORAL

Project FUN, a culturally tailored online nutrition and physical activity program is based on the Health Promotion/ Transtheoretical Model. It includes 8 modules offered in a password-protected learning management system along with a workbook also used to assure intervention completion.

Control

The control group participated in usual school activities only completing pre and post measures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Beneo Synergy 1

Intervention Type: DIETARY_SUPPLEMENT

Project FUN

Project FUN, a culturally tailored online nutrition and physical activity program is based on the Health Promotion/ Transtheoretical Model. It includes 8 modules offered in a password-protected learning management system along with a workbook also used to assure intervention completion.

Intervention Type: BEHAVIORAL

Other Intervention Names

oligofructose enhanced inulin

Eligibility Criteria

Inclusion Criteria

• 4th- 5th grade students at two private urban schools where 98% were eligible for free or reduced fee lunch.

Exclusion Criteria

• Parents indicated their child had taken an antibiotic in the last month since antibiotics can change intestinal flora though none required exclusion for this reason or for illness preventing participation.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: collaborator

Marquette University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2411

Identifier Type: -

Identifier Source: org_study_id