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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610374
• Other study ID #: 15-1692
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2020

Study information

• Verified date: January 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Agrarian Diet
A diet higher in carbohydrates and lower in fats and sugars
• Western-type Diet
A diet higher in fats and lower in carbohydrates

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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