Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors (PowerUp)
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|ClinicalTrials.gov Identifier: NCT00477477|
Recruitment Status : Terminated (Inadequate enrollment and lack of funds.)
First Posted : May 23, 2007
Last Update Posted : October 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity Dyslipidemia Insulin Resistance Hypertension||Other: Diet||Not Applicable|
The prevalence of obesity and overweight among children is high, and increasing. Metabolic syndrome, a recently recognized consequence of obesity, is known to confer an elevated risk for cardiovascular (CV) disease and diabetes type 2 in adults. The primary treatment for metabolic syndrome is lifestyle modification, including dietary changes. However, little is known about how dietary composition, as distinct from decreased caloric intake and weight loss, alters metabolic syndrome abnormalities in children. Moreover, the optimal pediatric nutritional strategy for prevention and treatment of metabolic syndrome is unknown. The overall goal of this research protocol is to evaluate two nutritional approaches to pediatric metabolic syndrome in post-pubertal overweight adolescents, a low saturated fat diet and a low glycemic load (GL) diet. The design of the protocol is a short-term, modified feeding study that evaluates the efficacy of these two nutritional approaches with equal weight loss goals. Outcome measures will include the percent changes from baseline to the end of the intervention period (8 weeks) in metabolic abnormalities, inflammatory cytokines and adipokines, and non-invasive tests of vascular function. Metabolomic profiles are measured at baseline and 8 weeks in a subset of the participants.
To facilitate compliance and adherence, participants chose from a menu of food choices and food will be delivered to participants homes to supply most of the meals and snacks participants consume. Participants will receive weekly personal nutritional counseling to enhance compliance with frequent phone follow-up. Subsequent to the feeding portion of the intervention, participants are counselled by phone at least on a monthly basis and the effects of this maintenance phase is measured at 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||September 2012|
Low glycemic load diet
Low glycemic load diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.
Active Comparator: 2
Low fat diet
Low saturated fat diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.
- Insulin resistance [ Time Frame: 8 weeks, 6 months ]
- Inflammation [ Time Frame: 8 weeks, 6 months ]
- dyslipidemia [ Time Frame: 8 weeks, 6 months ]
- blood pressure [ Time Frame: 8 weeks, 6 months ]
- coagulopathy [ Time Frame: 8 weeks, 6 months ]
- vascular function [ Time Frame: 8 weeks, 6 months ]
- liver function testing [ Time Frame: 8 weeks, 6 months ]
- Metabolomic profile [ Time Frame: baseline, 8 weeks ]The metabolomic profile of a subset of the participants will be measured at baseline and 8 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477477
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Sarah D. de Ferranti||Boston Children’s Hospital|