Hypertension Clinical Trial
Official title:
Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors
This study is designed to evaluate the efficacy of two diets, a low glycemic load diet and a low saturated fat diet, in the treatment of adolescents with some heart disease risk factors associated with being overweight, such as high blood pressure, pre-diabetes, and cholesterol problems. The objective of the study is to determine which diet improves these risk factors more. The design of the study is a modified feeding study, which requests that the participants eat all and only the food provided by the study for 8 weeks, most days per week. Dietary counseling by phone will continue between 2 and 6 months of the study and the effects of this maintenance period will be assessed at 6 months time.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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