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

NCT ID: NCT02610374

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-03-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cohort A

HIV-positive individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks.

Group Type: OTHER

Agrarian Diet

Intervention Type: OTHER

A diet higher in carbohydrates and lower in fats and sugars

Western-type Diet

Intervention Type: OTHER

A diet higher in fats and lower in carbohydrates

Cohort B

HIV-negative high-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks.

Group Type: OTHER

Agrarian Diet

Intervention Type: OTHER

A diet higher in carbohydrates and lower in fats and sugars

Western-type Diet

Intervention Type: OTHER

A diet higher in fats and lower in carbohydrates

Cohort C

HIV-negative low-risk individuals will be randomized to receive either an Agrarian diet or a Western-type diet for 4 weeks.

Group Type: OTHER

Agrarian Diet

Intervention Type: OTHER

A diet higher in carbohydrates and lower in fats and sugars

Western-type Diet

Intervention Type: OTHER

A diet higher in fats and lower in carbohydrates

Interventions

Agrarian Diet

A diet higher in carbohydrates and lower in fats and sugars

Intervention Type: OTHER

Western-type Diet

A diet higher in fats and lower in carbohydrates

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Lozupone, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

Countries

United States

Other Identifiers

15-1692

Identifier Type: -

Identifier Source: org_study_id