Prader-Willi Syndrome Macronutrient Study

December 13, 2016 updated by: Duke University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of Prader Willi syndrome confirmed by chromosome analysis (ie. interstitial deletion of paternally-derived chromosome 15q, uniparental maternal disomy or other chromosome 15 abnormalities)
  • age 5 years to 17 years
  • written informed consent and assent obtained and willingness to comply with the study schedule and procedures
  • free T4, TSH values in the normal range (either endogenous or with thyroxine replacement)
  • weight stable (BMI percentile fluctuation of <5 percentiles) over the preceding 2 months prior to the study

Exclusion Criteria:

  • presence of other clinically significant disease that would impact body composition including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders
  • concomitant use of medications known to affect body weight or investigational drug in the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Low carbohydrate diet
Low carbohydrate diet: 15%carb; 65%fat; 20% protein. This will be administered over 72 hour hospital stay.
Other: Low Fat diet
Low Fat diet: 65%carb; 15%fat; 20% protein
OTHER: Low Fat diet
Low fat diet: 65%carb; 15%fat; 20% protein. This will be administered over a 72 hour hospital stay.
Other: Low Carbohydrate diet
Low carbohydrate diet: 15%carb; 65%fat; 20% protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suppression of ghrelin
Time Frame: 10 hour fast following completion of dietary intervention
Fasting labs will be obtained immediately following dietary intervention. These labs will include total and active ghrelin.
10 hour fast following completion of dietary intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in satiety
Time Frame: During the 72 hour dietary intervention
Changes in subjective hunger will be assessed by an appetite and hyperphagia questionnaire validated for PWS children. This will be completed by the children, with assistance of their parents, at completion of the 72 hour dietary intervention.
During the 72 hour dietary intervention
Improvements in insulin sensitivity
Time Frame: During the 72 hour dietary intervention.
The analysis will include measurements of adiponectin, GLP-1, glucose, insulin, AST, ALT, insulin sensitivity and a detailed profile ("metabolomics") of amino acids, fatty acids, acylcarnitines, and adipocytokines on the day prior to and immediately following dietary intervention.
During the 72 hour dietary intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in inflammatory cytokine profile
Time Frame: During the 72 hour dietary intervention
The analysis will include measurements of adiponectin, GLP-1, glucose, insulin, AST, ALT, insulin sensitivity and a detailed profile ("metabolomics") of amino acids, fatty acids, acylcarnitines, and adipocytokines on the day prior to and immediately following dietary intervention.
During the 72 hour dietary intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Foundation for Prader-Willi Research

Investigators

  • Principal Investigator: Michael Freemark, MD, Duke University
  • Principal Investigator: Andrea M Haqq, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (ESTIMATE)

December 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00049226
  • SFR2382 (OTHER_GRANT: Foundation for Prader-Willi Research (US))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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