Status
Conditions
Treatments
About
In recent decades, the prevalence of obesity has increased dramatically in the United States. Obesity has been associated with an increased risk of the metabolic syndrome, which is characterized by a cluster of metabolic derangements, including insulin resistance, high blood sugar, high triglycerides, low high density lipoprotein (HDL) cholesterol levels, high blood pressure, and inflammation. Lifestyle interventions, including dietary modification, physical activity, and weight loss, form the basis of treatment for individuals with the metabolic syndrome. However, the optimal composition of the diet is not known at this time. Furthermore, due to hormonal and metabolic changes that accompany weight loss, most people find it very difficult to maintain significant weight reductions over time. As a result, weight regain is exceedingly common.
Full description
Several dietary patterns, including the Dietary Approaches to Stop Hypertension study diet (the DASH diet) and the low glycemic index diet (low GI diet), may be useful in the treatment of individuals with the metabolic syndrome, even if body weight stays the same. Novel findings from our own pilot study suggest that these dietary patterns may improve insulin resistance and some other features of the metabolic syndrome, even after just two weeks and in the absence of weight loss. In this important follow-up study, the metabolic effects of the DASH diet and the low GI diet will be compared to those of an Western-style control diet. At least 39 overweight, insulin-resistant volunteers with the metabolic syndrome will be studied during a 32-day inpatient admission. All food will be provided, and body weight will be kept stable throughout the study. Subjects will first undergo testing after consuming a Western-style diet for two weeks. They will then be randomized to one of three study diets: the DASH diet, the low GI diet, or the Western-style diet. Testing will again be conducted after 2 weeks of weight stability on the study diet. Testing will include the assessment of insulin sensitivity and other metabolic parameters, such as blood sugar and cholesterol levels, blood pressure, and inflammation. This study will provide important information about the effects of these promising dietary patterns on features of the metabolic syndrome, in the absence of weight loss.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Nonsmoking men and postmenopausal women, ages 18 - 65. Premenopausal women who would not be expected to have significant fluctuations in estrogen and progesterone levels during the study (e.g. those on continuous monophasic hormonal contraception) may be included in the study at the discretion of the PI or designated study staff.
Body mass index (BMI) of at least 27 kg/m2
Body weight < 200 kg (the weight limit of the Bod Pod® scale)
Evidence of insulin resistance, as suggested by any one of the following:
Willingness to consume only study food and drink for the duration of the study
Willingness to be randomized to any one of the three study diets
If applicable, willingness to maintain consistent intake of coffee and/or tea during the inpatient periods (due to the potential effects of these drinks on inflammatory markers)
Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study. At the PI's discretion, other nutritional supplements, such as iron, may also be continued during the study if they are deemed medically necessary and are unlikely to influence study results.
If applicable, willingness to continue current antihypertensive medications (especially angiotensin converting enzyme inhibitors and angiotensin receptor blockers, which may affect levels of inflammatory markers) at the same dose and schedule throughout the study,unless a change is advised by the subject's primary care provider or the study investigators
Willingness to avoid the use of non-steroidal anti-inflammatory drugs (NSAIDS), including low-dose daily aspirin, throughout the inpatient admission, (due to the potential effects of these agents on inflammatory markers).
at least two of the following:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
42 participants in 3 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal