Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients

Conditions
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HIV

Intervention / Treatment
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* Other: Agrarian Diet
* Other: Western-type Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort A<br>HIV-positive individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. | Other: Agrarian Diet<br>* A diet higher in carbohydrates and lower in fats and sugars<br>Other: Western-type Diet<br>* A diet higher in fats and lower in carbohydrates<br>|
| Other: Cohort B<br>HIV-negative high-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. | Other: Agrarian Diet<br>* A diet higher in carbohydrates and lower in fats and sugars<br>Other: Western-type Diet<br>* A diet higher in fats and lower in carbohydrates<br>|
| Other: Cohort C<br>HIV-negative low-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks. | Other: Agrarian Diet<br>* A diet higher in carbohydrates and lower in fats and sugars<br>Other: Western-type Diet<br>* A diet higher in fats and lower in carbohydrates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma IL-6 concentration (All Participants) | - 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. | 4 weeks | 
| Change in plasma IL-6 concentration (HIV-Infected Participants) | - 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiota composition