HIV
Conditions
Keywords
Gut microbiota composition
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.
Interventions
OTHERAgrarian Diet
A diet higher in carbohydrates and lower in fats and sugars
OTHERWestern-type Diet
A diet higher in fats and lower in carbohydrates
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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) * Negative pregnancy test (if female)
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed