This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Metabolic syndrome is classified on the basis of a constellation of CVD risk factors, including hypertension, glucose intolerance, abdominal obesity and dyslipidemia, which dramatically increase CVD risk. The prevalence of metabolic syndrome is significantly lower among individuals who consume the most whole grains, however no studies have employed whole grains as a potential treatment for metabolic syndrome. Subjects will be randomized to one of two energy-restricted diets for 3-months: intake of either six servings of whole grains per day or zero servings of whole grains per day. Subjects will be instructed, and required, to keep track of their daily food intake including their whole grain intake in a diet diary. Every other week, subjects will visit the GCRC and review their diet with the dietitian who will also discuss a nutritional topic of interest . At each visit we will record the subjects' weight, blood pressure, waist circumference and body composition. At baseline and at the end of the study we will measure metabolic syndrome criteria as well as weight, body composition, C-reactive protein (CRP), plasminogen activator inhibitor-1 (PAI-1), glucose and insulin response to an oral glucose tolerance test, and other measures of metabolic and reproductive function. At nine months following completion of the study, subjects will complete a 3-day diet record and go to the GCRC for measurement of their weight. For the primary outcome of difference in weight loss between the two diets, the two-sample t-test will be used. In the event that the distribution of weight loss is not normal, the nonparametric Wilcoxon-Mann-Whitney test will be used. For all continuous primary and the secondary outcomes, a linear mixed-effects model will be fit to the data to assess within-diet as well as between-diet differences.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR010732-12
Application #
7378542
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
12
Fiscal Year
2006
Total Cost
$116,571
Indirect Cost
Name
Pennsylvania State University
Department
Type
Schools of Medicine
DUNS #
129348186
City
Hershey
State
PA
Country
United States
Zip Code
17033
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