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Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic

NCT04100109 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-07-11

No results posted yet for this study

Summary

This study will evaluate the feasibility and obtain a preliminary estimate of efficacy of feeding 15 g/day of a new novel prebiotic dietary fiber, termed polylactose, in 40 children (8-12 years old) with obesity (body mass index \[BMI\]-percentile \>/= 95th) who have magnetic resonance imaging (MRI)-confirmed non-alcoholic fatty liver disease \[NAFLD\] (hepatic fat fraction \>/= 5.5%), compared to a placebo of 15 g/d of cellulose, an inert dietary fiber.

Conditions

  • Obesity, Adolescent
  • Obesity, Childhood

Interventions

DIETARY_SUPPLEMENT

Polylactose

Polylactose 15 g/day

OTHER

Placebo

Cellulose 15 g/day

Sponsors & Collaborators

Principal Investigators

  • Justin Ryder, PhD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-05-01
Primary Completion
2028-07-31
Completion
2028-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04100109 on ClinicalTrials.gov