As the HIV population survives and ages, a new syndrome is being observed that appears to be affected by PI medications but is also seen independent of PI use. This syndrome is characterized by hyperlipidemia, lipodystrophy and insulin resistance. Elevated triglycerides are a common observation with or without hypercholesterolemia. Since statin do not reduce serum triglycerides and may be counter-indicated to lower serum cholesterol because of potential liver damage in the HIV+ population that are on PI, dietary interventions have been getting more attention. Literature suggests that a diet lower in fat with reduced levels of saturated fat relative to polyunsaturated fat, increased omega 3-fatty acids intake, high fiber, and use of carbohydrates lower in glycemic index may be beneficial when they were studied individually. We propose to use a nutrition intervention in a HIV+ population that has elevated triglycerides (>220 mg/dl) to test whether a diet that combines all of these factors can have a significant effect on reducing serum triglycerides. The nutrition intervention will be a low fat diet (25% of calories from fat) with a 1:1:1 ratio of Saturated:Monounsat: Polyunsaturated fat, high in fiber (40 g/day) with carbohydrates of lower glycemic index (< 70 whenever possible). This diet will contain 3 g/day of omega 3-fatty acids which will be supplemented with 3.0 g of omega 3-fatty acids from capsules to give a total of 6 g/day of omega 3-fatty acids and a ratio of n-6/n-3 of 4:1. In addition to measuring triglycerides, serum cholesterol and its sub-fractions will be determined as well as insulin area under the curve (AUC) and body composition using CT scan. HIV+ participants eligible for the study (N=100) would be randomized into a control or nutrition intervention group and be tested for changes after 3 weeks, 13 weeks and 6 months of intervention. During the first 3 weeks the intervention group will be given all their meals at the hospital General Clinical Research Center, followed by an additional 10 weeks in which some food products are supplied to them along with the continued use of omega 3-fatty acids supplements at 3 gms/day (in 10 capsules). After 13 weeks the participants will be asked to continue to take the omega 3-fatty acid capsules but food products high in n-3 fatty acids will not be supplied. A 6-month follow-up will then remeasure all the study parameters to determine if the nutrition intervention group had experienced an improvement of the listed risk factors compared to the control group.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK063619-03
Application #
6790644
Study Section
Special Emphasis Panel (ZRG1-AARR-6 (51))
Program Officer
Malozowski, Saul N
Project Start
2002-09-30
Project End
2007-07-31
Budget Start
2004-08-01
Budget End
2005-07-31
Support Year
3
Fiscal Year
2004
Total Cost
$277,375
Indirect Cost
Name
Tufts University
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
039318308
City
Boston
State
MA
Country
United States
Zip Code
02111