This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. The objective of this trial is to examine the long-term effects of a diet low in carbohydrates, as compared to one low in fat, on CVD risk factors, including blood pressure (BP), body weight and composition, serum lipids, plasma glucose, insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among obese adults. This study is a randomized controlled trial with a two-arm, parallel design. Using a stratified, blocked randomization scheme, eligible participants are assigned to either a low-carbohydrate intervention diet or a low fat control diet (instructions for each group will include intensive one-on-one counseling with a dietitian every week for 4 weeks followed by 10 biweekly sessions and 6 monthly sessions). This trial has 80% statistical power to detect clinically important changes in CVD risk factors. In order to conduct the trial, we will recruit 130 study participants with a body mass index of 30-45 kg/m2 using mass mailings, workplace screenings, community health fairs, and media advertisements in the Greater New Orleans, LA area;randomize the eligible participants to either a low-carbohydrate intervention diet for 12 months or a low fat diet for 12 months;provide diet instructions for each participant including intensive one-on-one counseling with a dietitian for a total of 15 sessions over 12 months;measure CVD risk factors (systolic and diastolic BP, body weight, body composition, waist circumference, lipid profiles, glucose and insulin levels, and levels of CRP and adipocytokines) in all participants at baseline, 3, 6, and 12 months of follow-up;and examine the differences in these risk factors among persons assigned to the low-carbohydrate intervention compared to those assigned to the low fat intervention.
Showing the most recent 10 out of 207 publications
