Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic

Launched by UNIVERSITY OF MINNESOTA · Sep 20, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of dietary fiber called polylactose, which researchers hope can help children with obesity and a liver condition known as non-alcoholic fatty liver disease (NAFLD). The study will involve 40 children aged 8 to 12 years who have a higher-than-normal body weight and confirmed NAFLD. Participants will receive either 15 grams of polylactose each day or a placebo, which is an inactive substance, for comparison. The goal is to see if polylactose can have a positive effect on their health.

To be eligible for the trial, children need to be between 8 and 12 years old, have a body mass index (BMI) in the 95th percentile or higher, and show signs of liver issues. However, children with certain medical conditions or those taking specific medications won't be able to participate. The trial is not yet recruiting participants, but once it starts, children who join will help researchers learn more about how this new fiber might help improve their health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)