Status:
WITHDRAWN
Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic
Lead Sponsor:
University of Minnesota
Conditions:
Obesity, Adolescent
Obesity, Childhood
Eligibility:
All Genders
8-12 years
Phase:
NA
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) w...
Detailed Description
Approximately 13% of all children (2 - 19 years old) are afflicted with NAFLD with the prevalence of NAFLD increasing to 60-80% among youth with obesity. NAFLD is characterized by excessive deposition...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Diagnosed monogenic obesity
- History of cancer
- Untreated thyroid disorder
- Current or recent (\< 6 months prior to enrollment) use of medication(s) associated with weight gain (e.g. atypical anti-psychotics)
Key Trial Info
Start Date :
May 1 2028
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04100109
Start Date
May 1 2028
End Date
July 31 2028
Last Update
July 11 2025
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