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

Not Applicable

Completed

• Conditions: HIV

• 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.

Study Timeline

• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Study Start: 2016-03
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States