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Prader-Willi Syndrome Macronutrient Study

NCT02011360 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-12-14

No results posted yet for this study

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.

Conditions

  • Prader Willi Syndrome
  • Syndromic Obesity
  • Childhood Obesity

Interventions

OTHER

Low Carbohydrate diet

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

OTHER

Low Fat diet

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

Sponsors & Collaborators

  • Foundation for Prader-Willi Research

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Michael Freemark, MD · Duke University

  • Andrea M Haqq, MD · University of Alberta

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02011360 on ClinicalTrials.gov