Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- University of Colorado, Denver
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in plasma IL-6 concentration (All Participants)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The primary objective is to assess the effect of short-term diet modification on the microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative controls in the United States.
Detailed Description
This is a randomized clinical trial. Fifty (50) Antiretroviral therapy (ART)-treated Human immunodeficiency virus (HIV) positive participants, 24 HIV negative controls matched for age and sex, and 24 HIV negative controls from a population at high risk for contracting HIV will be recruited into 3 cohorts. All participants will undergo a 4 week diet modification and will be randomly assigned to receive either an Agrarian diet or a Western-type diet. For the first 2 weeks, food will be provided to the participant, followed by an additional 2 weeks where participants will be provided a diet menu with recipes to prepare themselves. There will be 4 study visits and participation will last for up to 2 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HIV-infected cohort (Cohort A)
- •Documentation of HIV-1 infection defined as a positive antibody test or plasma HIV-1 RNA (ribosomal ribonucleic acid).
- •Treated with ART (minimum of three antiretroviral drugs in regimen) for at least 12 months with no changes in antiretroviral drugs over the past 6 months
- •Plasma HIV-1 RNA ≤ 50 copies/mL in the preceding 6 months.
- •HIV-negative cohorts (Cohort B and C)
- •Documentation of a negative HIV-1 antibody test
- •All Cohorts
- •Age 18 to 65 years
- •Body mass index between 21-29 kg/m2 (non-obese)
- •Stable weight for at least 3 months (≤15% change in body weight)
Exclusion Criteria
- •Use of systemic (oral or parenteral) antibiotics within two months prior to study entry
- •Active chronic infection such as hepatitis B or C or an active malignancy that requires systemic chemotherapy.
Outcomes
Primary Outcomes
Change in plasma IL-6 concentration (All Participants)
Time Frame: 4 weeks
- The change in plasma IL-6 from baseline to week 4 for all participants (Cohorts A, B \& C) assigned to the Agrarian diet group will be compared to participants assigned to the Western diet group.
Change in plasma IL-6 concentration (HIV-Infected Participants)
Time Frame: 4 weeks
- The change in plasma IL-6 from baseline to week 4 for HIV-infected participants (Cohort A) assigned to an Agrarian diet will be compared to HIV-uninfected participants (Cohort B \& C) assigned to an Agrarian diet.