The purpose of this R03 (PA-02-120) Small Grant Research Program is to test the feasibility of conducting a controlled dietary study, supplemented with 4 grams of omega-3 fatty acids (fish oil) per day to reduce serum triglyceride levels in HIV/AIDS patients taking highly active antiretroviral therapies (HAART) with Protease Inhibitors. In recent years/cardiovascular disease (CVD) risk factors have been recognized among individuals living with HIV/AIDS. CVD risk factors in HIV have been associated with the medications used to manage HIV. Strong associations between a specific class of HIV medication, protease inhibitors (PI), has been implicated in elevating serum levels of triglycerides in people using these agents. Effective treatments are needed to prevent the sequelae of CVD from further complicating the disease process, management and quality of life. Current treatments for hypertriglyceridemia in HIV, are not always effective and can be dose limited due to interactions with HAART regimens. 32 men and women diagnosed with HIV/AIDS taking PI-HAART with elevated levels of fasting serum triglyceride will be randomized to 1 of 2 conditions in a prospective, placebo-controlled, parallel group, feasibility clinical trial. The 2 conditions are: Condition 1, subjects will receive prepared meals using usual foods based on the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) dietary guidelines supplemented with 4 grams offish oil per day; and Condition 2 (control group), subjects will receive prepared meals using usual foods based on the NCEP TLC dietary guidelines with placebo. All subjects will attend one intake/screening, one baseline and 16 sessions over 10 weeks. All subjects will also be administered the same instruments, undergo the same evaluations and laboratory testing for the duration of the study. Subjects will be encouraged to maintain usual level of physical activity for the duration of the study.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Small Research Grants (R03)
Project #
5R03NR009476-02
Application #
7126029
Study Section
AIDS Clinical Studies and Epidemiology Study Section (ACE)
Program Officer
Hare, Martha L
Project Start
2005-09-23
Project End
2009-07-31
Budget Start
2006-08-01
Budget End
2009-07-31
Support Year
2
Fiscal Year
2006
Total Cost
$78,608
Indirect Cost
Name
Columbia University (N.Y.)
Department
Type
Schools of Nursing
DUNS #
621889815
City
New York
State
NY
Country
United States
Zip Code
10032
Capili, Bernadette; Anastasi, Joyce K (2013) Exploratory study: evaluating the effects of fish oil and controlled diet to reduce triglyceride levels in HIV. J Assoc Nurses AIDS Care 24:276-82