Clinical trial NCT05671731: Combining Prebiotic and Diet/Physical Activity Educational Program Effects on Body Composition and Intestinal Microbiota in Children
Official title: The Effect of Combining Prebiotic Treatment With a Diet/Physical Activity Educational Program on Body Composition and Intestinal Microbiota in 4th and 5th Grade Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Keywords: prebiotics
Gastrointestinal Microbiome
Hispanic or Latino
Lead sponsor: Marquette University
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2023-01-05
Enrollment: 123
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized controlled feasibility trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Body mass index percentile mean change from baseline after 12 weeks
timeFrame: Pre and after 12-week intervention
Secondary outcomes:
measure: Body fat percentage mean change from baseline after 12 weeks
timeFrame: Pre and after 12-week intervention
measure: Gut microbiota mean change from baseline after 12 weeks (Intervention group only)
timeFrame: Pre and after 12-week intervention
Other outcomes:
measure: Dietary fat percentage mean change from baseline after 12 weeks
timeFrame: Pre and after 12-week intervention
measure: Physical activity mean change from baseline after 12 weeks
timeFrame: Pre and after 12-week intervention
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