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

Fudan University

Status: Not yet enrolling

Conditions: Hiv; Diet, Healthy; Atherosclerosis

Treatments: Other: dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06560840

SZ-2024-008

Details and patient eligibility

About

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 older people living with HIV (PLWH).

Full description

The investigators utilize a pragmatic randomized controlled trial design to evaluate the effectiveness of dietary intervention in real-world conditions, without strict control, thereby enhancing the generalizability and clinical applicability of our study findings. Participants at Shenzhen Third People's Hospital, exhibiting HIV with CVD risk will be enrolled. Upon providing informed consent, participants will undergo dynamic randomization into intervention and control groups, aiming for a 1:1 ratio while preserving maximum unpredictability. 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. Primary outcomes will assess ASCVD risk via the pooled cohort equation and evaluate gut microbiota diversity and composition. Secondary outcomes will encompass biomarkers and predictors associated with atherosclerotic cardiovascular disease, as well as symptoms related to the condition.

Enrollment: 110 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines;
2. Aged 40 years and above;
3. at risk of CVD: having any two of those risk factors: dyslipidemia, DM or elevated blood glucose, smoking, hypertention or elevated blood pressure, metabolic syndrome,overweight/obesity; or PCE score>5%,
4. Those with a predicted survival time of >1 year;
5. No plans to leave the depth in the next 3 months;
6. Voluntary participation in this study and signing the informed consent

Exclusion criteria

1. Those with a previous history of CVD;
2. Those with HIV-related neurocognitive impairment, Alzheimer's disease or dementia, and a variety of serious opportunistic infections;
3. Currently suffering from malignant tumors, gastrointestinal diseases; People with an aversion to eating;
4. Allergic to nuts and fish;
5. People who take medicinal calcium >1000 mg per day or omega-3 supplements;
6. Plan to become pregnant within 6 months;
7. Are participating in other HIV-related or dietary intervention-related scientific research programs.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

intervention group

Experimental group

Description:

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

Treatment:

Other: dietary intervention

control group

No Intervention group

Description:

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