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

NCT06279819 | Not Yet Recruiting

• 1 other identifier: 2024-008
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Hiv; Cardiovascular Diseases; Diet, Healthy

Outcome Measures

Primary Outcomes (2)

• ASCVD risk estimated by the PCE

  Use the pooled cohort equation to estimate the participants' 10-year ASCVD risks

  baseline, 3-month and 6-month

• The composition of gut microbiota

  Fecal samples will be collected from study participants, and the composition of gut microbiota will be analyzed using 16S rRNA technology. Diversity Analysis: Bacterial richness and phylogenetic diversity within samples will be assessed using Faith's Phylogenetic Diversity and richness metrics. Taxonomic Composition: Relative abundance of specific bacterial taxa will be determined through statistical analyses performed using phyloseq v. 1.26 and ggplot2 v. 3. Differential Abundance: A differential abundance analysis of Operational Taxonomic Units will be conducted. Beta Diversity: Differences in gut bacterial patterns among subjects consuming different diets will be evaluated using Bray Curtis dissimilarity, Weighted UniFrac, and Unweighted UniFrac metrics. Multivariate Analysis: Principal Coordinates Analysis will be performed to assess variations in the microbiome associated with dietary interventions.

  baseline and 3-month

Secondary Outcomes (4)

• fasting blood lipids

  baseline, 3-month and 6-month

• blood pressure

  baseline, 3-month and 6-month

• BMI

  baseline, 3-month and 6-month

• ASCVD symptoms

  baseline, 3-month and 6-month

Study Arms (2)

intervention group

EXPERIMENTAL

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. The intervention will span three months, followed by a three-month follow-up period.

Dietary Supplement: gut microbiota-targeted dietary intervention

control group

NO INTERVENTION

The control group will continue routine follow-up and health education practices.

Interventions

gut microbiota-targeted dietary intervention DIETARY_SUPPLEMENT

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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines (2021 edition);
• Aged 18 years and above;
• PCE predicted ASCVD risk of 5% - \<7.5%;
• Those with a predicted survival time of \>1 year;
• No plans to leave the depth in the next 3 months;
• Voluntary participation in this study and signing the informed consent.

You may not qualify if:

• Those with a past history of CVD;
• Those with HIV-related neurocognitive disorders and various serious opportunistic infections;
• Those with diabetes mellitus;
• Known nut allergy;
• Planning to become pregnant within 6 months;
• Are on lipid-lowering therapy or using any interfering medications or diets;
• Are participating in other HIV-related or dietary intervention-related scientific research programs.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)