CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Experimental: Low-fructose, reduced carbohydrate diet +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02116192
NCT02116192N/ACompleted
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Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents

University of Wisconsin, Madison·interventional·Posted Apr 16, 2014·Updated Oct 11, 2018

In Brief

A clinical study evaluating Experimental: Low-fructose, reduced carbohydrate diet and General Healthy Diet for Non-alcoholic Fatty Liver Disease. Completed, enrolled 28 participants across 1 site.

Detailed Summary

This research study intends to learn about whether early intervention can help to prevent non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to join the study. Patients who agree to participate in the study will be randomized into either the intervention group or the control group. The intervention group will follow a low-fructose diet. In addition, participants will be asked to return to the clinic for 4 follow-up visits during a 6-month interval.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-alcoholic Fatty Liver Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 16, 2014
Enrollment StartApr 1, 2014
Primary CompletionJul 1, 2016
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.2 years ago

Interventions

Experimental: Low-fructose, reduced carbohydrate dietbehavioral

Low Carbohydrate (Low Fructose and Sucrose) Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg;40-45% CHO, 20-25% Protein, 30-40% Fat) ● Aim for less than 25g fructose daily.

General Healthy Dietbehavioral

Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat