Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic

NCT04100109 | Withdrawn

• 1 other identifier: PEDS-2019-27933
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in hepatic fat fraction

  The primary efficacy endpoint for this study will be the change in hepatic fat fraction from baseline to week 26

  Subjects will have MR Spectroscopy at Baseline, Week 8 and Week 26

Study Arms (2)

Polylactose

ACTIVE COMPARATOR

Subjects randomized to this arm of the study will be asked to consume 15 grams/day of foods containing polylactose

Dietary Supplement: Polylactose

Placebo

ACTIVE COMPARATOR

Subjects randomized to this arm of the study will be asked to consume 15 grams/day of foods containing cellulose, which is an inert dietary fiber, and which will act as our placebo for this project.

Other: Placebo

Interventions

Polylactose DIETARY_SUPPLEMENT

Polylactose 15 g/day

Polylactose

Placebo OTHER

Cellulose 15 g/day

Placebo

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-12 years old
• Diagnosis of obesity: BMI percentile \>/= 95th (using age- and sex- based Center for Disease Control definitions) or BMI \>/= 30 kg/m2
• Elevated alanine aminotransferase (ALT) more than twice the upper limit of normal by gender (\>/= 44 U/L for girls, \>/= 50 U/L for boys) within 6 months prior to screening or diagnosis of NAFLD from ultrasound or MRI within 6 months of screening or participants with biopsy-proven NASH within 12 months of screening

You may not qualify if:

• ALT \> 250 U/L at screening
• History of significant alcohol intake or current use
• Impaired fasting glucose (\> 100 mg/dL)
• Diabetes (type 1 or 2)
• Current or recent (\< 60 months prior to enrollment) use of weight loss medication(s)
• Vitamin E supplementation
• Previous bariatric surgery
• Use of metformin
• Metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatable
• Recent initiation (\< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s)
• Known hypothalamic or pituitary dysfunction
• Tobacco use
• Gilbert's syndrome
• Any known causes of liver disease (except NAFLD and NASH)
• Significant renal dysfunction as calculated by estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m2

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin Ryder, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start (Estimated): May 1, 2028
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 11, 2025

Record last verified: 2025-07