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Completed

NCT Number: NCT05671731

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

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?

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beneo Synergy 1

Dietary Supplement

Other names: oligofructose enhanced inulin

Project FUN

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.

Primary outcomes

  1. Body mass index percentile mean change from baseline after 12 weeks

    Time frame: Pre and after 12-week intervention

    Weights to the nearest tenth of a pound were collected using a Seca model 8761321004 scale. Heights in stocking feet were measured to the nearest hundredth of an inch with a stadiometer (Seca Model 213, Hanover, MD, USA). Body mass index percentile was calculated using the Centers for Disease Control and Prevention school algorithm including birth date, measurement date, height, and weight

Secondary outcomes

  1. Body fat percentage mean change from baseline after 12 weeks

    Time frame: Pre and after 12-week intervention

    Measured with the Omron HBF-306C hand-held bioimpedance monitor

  2. Gut microbiota mean change from baseline after 12 weeks (Intervention group only)

    Time frame: Pre and after 12-week intervention

    Genomic markers of stool samples were analyzed by Roche 454 pyrosequencing of fecal 16S rDNA and validated by quantitative polymerase chain reaction.

Other outcomes

  1. Dietary fat percentage mean change from baseline after 12 weeks

    Time frame: Pre and after 12-week intervention

    A 21-item, five-option response format measure was used developed by Prochaska JJ, Sallis JF, Rupp J. Screening measure for assessing dietary fat intake among adolescents.

  2. Physical activity mean change from baseline after 12 weeks

    Time frame: Pre and after 12-week intervention

    Prochaska JJ, Sallis JF, Long B. A physical activity screening measure for use with adolescents in primary care.

Sponsors and collaborators

Lead sponsor

Marquette University

Other

Collaborators

  • Medical College of Wisconsin

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 5, 2023
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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