Prader-Willi Syndrome Macronutrient Study
|ClinicalTrials.gov Identifier: NCT02011360|
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : December 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Prader Willi Syndrome Syndromic Obesity Childhood Obesity||Other: Low Carbohydrate diet Other: Low Fat diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evidence-Based Approach to Dietary Management of Prader-Willi Syndrome (PWS)|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
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
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
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011360
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||Michael Freemark, MD||Duke University|
|Principal Investigator:||Andrea M Haqq, MD||University of Alberta|