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Effectiveness of Gut Microbiota-targeted Diatery Intervention Among People Living With HIV

NCT06498401 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-07-12

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 atherosclerotic cardiovascular disease (ASCVD) prevention and evaluate its effectiveness in preventing ASCVD among people living with HIV (PLWH).

Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly healthy diet guidance 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 targeted at gut microbiota. Each participant's dietary habits,food preferences and economic level were taken into account. The dietary intervention was delivered by sending meals. 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. Meals will be delivered three times a week for a 12-week intervention period. Guided dietary follow-up was conducted through WeChat or telephone follow-up. The researcher will provide cooking instruction or dietary pattern guidance every two weeks.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-20
Primary Completion
2025-01-31
Completion
2025-04-30

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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 NCT06498401 on ClinicalTrials.gov