Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT02011360
Study type Interventional
Source Duke University
Contact
Status Completed
Phase N/A
Start date May 2014
Completion date May 2016

See also
  Status Clinical Trial Phase
Recruiting NCT05437406 - Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC) N/A
Completed NCT03297541 - Healthy Kids I-PAL N/A
Completed NCT05527938 - Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children N/A
Completed NCT05501392 - South Texas Early Prevention Studies PreK N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Active, not recruiting NCT03342092 - Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté N/A
Completed NCT06239662 - Therapeutic Education Groups for Childhood Obesity N/A
Withdrawn NCT02767830 - Cleveland Kids Run N/A
Not yet recruiting NCT02889406 - Motivation Approach for Childhood Obesity Treatment N/A
Completed NCT03245164 - The Effects of Group Exercise and Basketball on Obese Children N/A
Completed NCT02559076 - The Eat Right Emirates Healthy Lifestyle Study N/A
Completed NCT02484976 - Brain Activation and Satiety in Children: Functional Magnetic Resonance Imaging N/A
Completed NCT01977105 - Healthy Growth Abbreviated Pilot Study N/A
Completed NCT02087774 - Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children N/A
Completed NCT01821313 - CASH- Children Active to Stay Healthy N/A
Completed NCT01789671 - Peer Counseling in Family-Based Treatment for Childhood Obesity N/A
Completed NCT01849315 - Effects of Physical Activity on Disease Risk Factors N/A
Completed NCT02637752 - Nutrition and Physical Activity Counselling N/A
Completed NCT02799433 - Evaluation of the Healthy Apple Program in San Francisco N/A
Completed NCT00854334 - Co-existent Obstructive Sleep Apnea (OSA) and Obesity: Finding Non-exercise Activity Thermogenesis (NEAT) Targets for Intervention N/A