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Effectiveness of Gut Microbiota-targeted Dietary Intervention Among HIV-infected Patients

NCT06279819 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-02-28

No results posted yet for this study

Summary

The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are:

* Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease.
* Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients.
* Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease.

Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months.

Conditions

Interventions

DIETARY_SUPPLEMENT

gut microbiota-targeted dietary intervention

The dietary intervention used the dietary intervention plan constructed in Phase 2, on the basis of which each study participant's individual dietary habits, food preferences and economic level were taken into account. The dietary intervention was delivered by sending fresh ingredients. To ensure the freshness and quality of the ingredients, 2 dedicated researchers were jointly responsible for the procurement of fresh ingredients, which were purchased through regular channels on Monday, Wednesday and Friday mornings. Ingredients will be delivered three times a week for a 12-week intervention period. The initial food items to be sent include: 90g of fish rich in omega-3 fatty acids; 300g of vegetables and/or legumes, and 200g of fruits; 30g of nuts; and a cup of probiotic yogurt. Guided dietary follow-up was conducted through video viewing and WeChat or telephone follow-up. The researcher will provide cooking instruction or dietary pattern guidance by sending videos every two weeks.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279819 on ClinicalTrials.gov