Overweight Clinical Trial
Official title:
Two Diets With Exercise in Abdominal Obesity: Cardiovascular Effects
Abdominal obesity, which is affected by a lack of physical activity and excess weight, put people at an increased risk of cardiovascular disease. This study will compare the effects of two different dietary approaches to weight loss, each combined with exercise, for their effects on cardiovascular factors that are early predictors of future cardiovascular disease in overweight and obese people with excessive weight around their waist. The two diets are a low-carbohydrate versus a more traditional low-fat, low calorie diet.
Abdominal obesity is a condition that is largely influenced by a poor diet and physical
inactivity. This condition has adverse effects on heart and blood vessel structure and
function, including left ventricular diastolic dysfunction, endothelial vasodilator
dysfunction, and increased vascular stiffness, each of which increase the risk of
cardiovascular disease. Reducing the amount of calories consumed and increasing physical
activity are both important factors for losing weight, increasing fitness, and improving
blood glucose control. However, little research has been conducted on comparing different
diet approaches combined with exercise for their effects on general and abdominal obesity,
fitness, heart and blood vessel structure and function, and heart disease risk factors. The
purpose of this study is to determine whether people who follow low-carbohydrate diet or a
low-fat, low-calorie diet, each combined with a supervised experience similar improvements
in cardiovascular and in body composition and health.
This study will enroll people who are overweight or obese and abdominal obesity, defined as
a waist to hip ratio greater than 1, or a waist size of 40" or greater in men or 35" or
greater in women. Participants will attend baseline study visits and complete blood pressure
measurements; muscle strength measurements; a treadmill test to evaluate cardiovascular
fitness; an echocardiogram to obtain images of the heart; tests to measure blood vessel
function; a dual energy x-ray absorptiometry (DEXA) scan to measure body fat, muscle tissue,
and bone density; questionnaires to assess physical activity levels, quality of life, and
mood; and a blood collection. A portion of blood will be stored for future genetic testing.
Women will also provide a urine sample for pregnancy testing. Participants will also keep a
food diary for 3 days. Participants will then be randomly assigned to either a
low-carbohydrate or a low-fat, low-calorie weight loss diet, each combined with a supervised
exercise program. . The exercise program will be done three times a week for 6 months. Each
session will last 1 to 1 ½ hours and will include aerobic exercise and weight training.
All participants will attend study visits with a dietitian for weight loss counseling and
monitoring once a week during Months 1 and 2, and every other week in Months 3 through 6. At
each of these visits, participants' weight will be measured.
At the end of Month 6, all participants will attend a study visit for repeat baseline
testing. In addition, there will another test for vascular function, BP, weight, and waist
and hip measurements at the time a participant loses ten pounds.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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