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

Obesity, Childhood Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05671731
• Other study ID #: 2411
• Status: Completed
• Phase: N/A
• Start date: November 13, 2012
• Est. completion date: April 11, 2013

Study information

• Verified date: December 2022
• Source: Marquette University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 11, 2013
• Est. primary completion date: April 11, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Dietary Supplement:
• Beneo Synergy 1

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Marquette University	Medical College of Wisconsin

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary fat percentage mean change from baseline after 12 weeks	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.	Pre and after 12-week intervention
Other	Physical activity mean change from baseline after 12 weeks	Prochaska JJ, Sallis JF, Long B. A physical activity screening measure for use with adolescents in primary care.	Pre and after 12-week intervention
Primary	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	Pre and after 12-week intervention
Secondary	Body fat percentage mean change from baseline after 12 weeks	Measured with the Omron HBF-306C hand-held bioimpedance monitor	Pre and after 12-week intervention
Secondary	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.	Pre and after 12-week intervention