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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: Agrarian Diet; Other: Western-type Diet

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Catherine Lozupone, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Gut microbiota composition
• Other Study ID Numbers: 15-1692