An interventional study of Beneo Synergy 1 and Project FUN in Obesity, Childhood, sponsored by Marquette University. Completed. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Marquette University · Not applicable, Interventional, and Prevention
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 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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 123 is above the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Marquette University is the lead sponsor of 36 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: Beneo Synergy 1 · Behavioral: Project FUN
The control group participated in usual school activities only completing pre and post measures.
Also known as: oligofructose enhanced inulin
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.
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
Time frame: Pre and after 12-week intervention
Body fat percentage mean change from baseline after 12 weeks
Measured with the Omron HBF-306C hand-held bioimpedance monitor
Time frame: Pre and after 12-week intervention
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.
Time frame: Pre and after 12-week intervention
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.
Time frame: Pre and after 12-week intervention
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.
Time frame: Pre and after 12-week intervention
No study locations are listed for this record.
Plan to share: No — At this time there is no data repository for sharing of individual data.
No publications or documents are linked to this record.
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Marquette University