Obesity Clinical Trial
Official title:
Effects of the Atkins Diet Versus a Low Fat Diet on Endothelial Function, Lipid Profiles, and Systemic Markers of Inflammation
The purpose of this research is to assess the effects of a low-carbohydrate (modified Atkins) diet versus a low fat (Heart Healthy) diet on cardiovascular health.
The purpose of this study is to compare the effects of a modified Atkins diet (low
carbohydrate and low calorie) and a traditional heart healthy diet (low fat and low calorie)
on biochemical markers of inflammation and metabolism, anthropometric measurements, vascular
studies of endothelial function, adipose tissue composition, and patient compliance and
satisfaction over a twelve week period in healthy men and women. Patients will be recruited
from the Nutrition and Weight Management Center at Boston Medical Center. Enrolled subjects
will be randomly assigned to a reduced calorie diet (either the Atkins diet or a traditional
heart healthy diet), and will be counseled by a dietitian and a physician throughout the
study period. The patients will have physical exams, labs, vascular studies of endothelial
function, and adipose tissue biopsies at baseline and at twelve weeks to assess progress.
Participants dietary compliance will be assessed using food journals and 24 hour recall.
The Atkins diet appears to have potential to reverse the epidemic of obesity-linked
cardiovascular disease (CVD) in the United States. Obesity is in effect an inflammatory
state in which adipose (fat) tissue releases adipokines- small, inflammatory proteins. High
adipokine levels in the blood lead to an inflammatory response, ultimately damaging the
endothelial cells which line the blood vessels and increases the risk of vascular disease.
Ultimately the effects of these two different diets will be analyzed to help determine if a
low carbohydrate, low calorie diet is more beneficial than a traditional heart healthy diet
(low fat, low calorie) at reducing the systemic inflammatory response by using physical exam
measures, inflammatory blood markers, vascular ultrasound studies, and adipose tissue
biopsies.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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