Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients
- Conditions
- HIV
- Interventions
- Other: Agrarian DietOther: Western-type Diet
- Registration Number
- NCT02610374
- Lead Sponsor
- University of Colorado, Denver
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
-
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)
- Negative pregnancy test (if female)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort C Western-type Diet HIV-negative low-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. Cohort B Western-type Diet HIV-negative high-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. Cohort C Agrarian Diet HIV-negative low-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. Cohort A Western-type Diet HIV-positive individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. Cohort B Agrarian Diet HIV-negative high-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. Cohort A Agrarian Diet HIV-positive individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks.
- Primary Outcome Measures
Name Time Method Change in plasma IL-6 concentration (All Participants) 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) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Colorado Denver
🇺🇸Aurora, Colorado, United States