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

Primary Purpose

Obesity, Childhood

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Beneo Synergy 1
Project FUN
Sponsored by
Marquette University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring prebiotics, Gastrointestinal Microbiome, Hispanic or Latino

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Body mass index percentile mean change from baseline after 12 weeks
    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 Outcome Measures

    Body fat percentage mean change from baseline after 12 weeks
    Measured with the Omron HBF-306C hand-held bioimpedance monitor
    Gut microbiota mean change from baseline after 12 weeks (Intervention group only)
    Genomic markers of stool samples were analyzed by Roche 454 pyrosequencing of fecal 16S rDNA and validated by quantitative polymerase chain reaction.

    Full Information

    First Posted
    December 20, 2022
    Last Updated
    December 20, 2022
    Sponsor
    Marquette University
    Collaborators
    Medical College of Wisconsin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05671731
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 13, 2012 (Actual)
    Primary Completion Date
    April 11, 2013 (Actual)
    Study Completion Date
    April 11, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marquette University
    Collaborators
    Medical College of Wisconsin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood
    Keywords
    prebiotics, Gastrointestinal Microbiome, Hispanic or Latino

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    cluster randomized controlled feasibility trial
    Masking
    Outcomes Assessor
    Masking Description
    Research assistants collecting data did not know group assignment of participants.
    Allocation
    Randomized
    Enrollment
    123 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group participated in usual school activities only completing pre and post measures.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Beneo Synergy 1
    Other Intervention Name(s)
    oligofructose enhanced inulin
    Intervention Type
    Behavioral
    Intervention Name(s)
    Project FUN
    Intervention Description
    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 Outcome Measure Information:
    Title
    Body mass index percentile mean change from baseline after 12 weeks
    Description
    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
    Time Frame
    Pre and after 12-week intervention
    Secondary Outcome Measure Information:
    Title
    Body fat percentage mean change from baseline after 12 weeks
    Description
    Measured with the Omron HBF-306C hand-held bioimpedance monitor
    Time Frame
    Pre and after 12-week intervention
    Title
    Gut microbiota mean change from baseline after 12 weeks (Intervention group only)
    Description
    Genomic markers of stool samples were analyzed by Roche 454 pyrosequencing of fecal 16S rDNA and validated by quantitative polymerase chain reaction.
    Time Frame
    Pre and after 12-week intervention
    Other Pre-specified Outcome Measures:
    Title
    Dietary fat percentage mean change from baseline after 12 weeks
    Description
    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.
    Time Frame
    Pre and after 12-week intervention
    Title
    Physical activity mean change from baseline after 12 weeks
    Description
    Prochaska JJ, Sallis JF, Long B. A physical activity screening measure for use with adolescents in primary care.
    Time Frame
    Pre and after 12-week intervention

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    At this time there is no data repository for sharing of individual data.

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

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