NCT04100109

Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic

Withdrawn NA Last updated 11 July 2025

What this trial tests

NA trial testing Polylactose in Obesity, Adolescent. Withdrawn.

Timeline

1 May 2028

Primary endpoint
31 July 2028

31 July 2028

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Start date	1 May 2028
Primary completion	31 July 2028
Estimated completion	31 July 2028

Drugs / interventions tested

• Polylactose
• Placebo

Conditions studied

• Obesity, Adolescent — all drugs for Obesity, Adolescent →
• Obesity, Childhood — all drugs for Obesity, Childhood →

Sponsor

University of Minnesota

Who can join

Adults 8 to 12, any sex, with Obesity, Adolescent or Obesity, Childhood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Can prebiotics help tackle the childhood obesity epidemic?
   Wang Y, Salonen A, Jian C. · · 2023 · cited 4× · PMID 37305030 · DOI 10.3389/fendo.2023.1178155