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Completed

NCT Number: NCT02011360

Prader-Willi Syndrome Macronutrient Study

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.

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Key information

Conditions

Prader Willi Syndrome Abnormalities, Multiple Body Weight Childhood Obesity Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Prader-Willi Syndrome Signs and Symptoms Syndromic Obesity

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low carbohydrate diet

Other

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

Low fat diet

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Foundation for Prader-Willi Research

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 13, 2013
Registry last updated
Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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