NCT05671731 is a NA clinical trial of Beneo Synergy 1 in Obesity, Childhood, sponsored by Marquette University.

Who is sponsoring NCT05671731?

NCT05671731 is sponsored by Marquette University.

What drugs are being tested in NCT05671731?

Interventions in NCT05671731: Beneo Synergy 1, Project FUN.

What condition does NCT05671731 study?

NCT05671731 studies Obesity, Childhood.

Is NCT05671731 still recruiting?

NCT05671731 is currently completed. Last updated 5 January 2023.

Last reviewed 2023-01-05 · How we verify

NCT05671731

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 5 January 2023

What this trial tests

NA trial testing Beneo Synergy 1 in Obesity, Childhood in 123 participants. Completed in 11 April 2013.

Timeline

13 November 2012

Primary endpoint
11 April 2013

11 April 2013

Quick facts

Lead sponsor	Marquette University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	123
Start date	13 November 2012
Primary completion	11 April 2013
Estimated completion	11 April 2013

Drugs / interventions tested

Beneo Synergy 1
Project FUN

Conditions studied

Obesity, Childhood — all drugs for Obesity, Childhood →

Sponsor

Marquette University

Who can join

Eligibility, any sex, with Obesity, Childhood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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?

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Obesity, Childhood

Currently open trials in the same condition.

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NCT06847373 — Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity · NA · recruiting
NCT06579079 — Improving Participation in Universal School Meals (USM) · NA · active not recruiting

Other Marquette University trials

Trials by the same sponsor.

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NCT06858293 — Mental Imagery to Improve Quadriceps Strength Post Anterior Cruciate Ligament Reconstruction: a Feasibility Study · NA · recruiting
NCT06734052 — Computer-guided Action Planning to Support Physical Activity (CAPPA) for Employees With Chronic Knee Symptoms · NA · completed
NCT06340893 — Exercise Training in Children With Communication Impairments · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05671731 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Marquette University
Last refreshed: 5 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05671731.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing