CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Low Carbohydrate diet +1 moreother
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/NCT02011360
NCT02011360N/ACompleted

Evidence-Based Approach to Dietary Management of Prader-Willi Syndrome (PWS)

Duke University·interventional·Posted Dec 13, 2013·Updated Dec 14, 2016

In Brief

A clinical study evaluating Low Carbohydrate diet and Low Fat diet for Prader Willi Syndrome and 2 related conditions. Completed, enrolled 10 participants across 2 sites in 2 countries.

Detailed Summary

The overall objective is to explore the mechanisms by which macronutrients regulate food intake and weight gain in Prader Willi Syndrome (PWS). Previous studies from the investigators' labs suggest that the increased appetite of PWS may be triggered or maintained by an increase in the levels of ghrelin, an appetite-stimulating hormone produced primarily by the stomach. This study will compare the effects of low carbohydrate diet versus low fat diet on levels of ghrelin, appetite suppressing hormones and markers of insulin sensitivity in patients with PWS. The investigators hypothesize that the low carbohydrate diet will suppress plasma active ghrelin and increase appetite-suppressing hormones to a greater degree and for longer duration than the low fat diet and will thereby reduce hyperphagia and increase satiety. The investigators also hypothesize that the low carb diet will improve hormonal and metabolic markers (fatty acids, amino acids and organic acids) of insulin sensitivity and inflammatory cytokine profiles of children with PWS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 13, 2013
Enrollment StartMay 1, 2014
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.6 years ago

Interventions

Low Carbohydrate dietother

Low carbohydrate diet: 15%carb; 65%fat; 20% protein

Low Fat dietother

Low Fat diet: 65%carb; 15%fat; 20% protein