Effectiveness of Gut Microbiota-targeted Diatery Intervention in Preventing Atherosclerotic Cardiovascular Disease Among Older People Living With HIV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Fudan University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Gut microbiota diversity and composition
Study Overview
Brief 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 older people living with HIV (PLWH).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines;
- •Aged 40 years and above;
- •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%,
- •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
Exclusion Criteria
- •Those with a previous history of CVD;
- •Those with HIV-related neurocognitive impairment, Alzheimer's disease or dementia, and a variety of serious opportunistic infections;
- •Currently suffering from malignant tumors, gastrointestinal diseases; People with an aversion to eating;
- •Allergic to nuts and fish;
- •People who take medicinal calcium >1000 mg per day or omega-3 supplements;
- •Plan to become pregnant within 6 months;
- •Are participating in other HIV-related or dietary intervention-related scientific research programs.
Arms & Interventions
intervention group
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
Intervention: dietary intervention (Other)
control group
The control group will continue routine follow-up and health education practices.
Outcomes
Primary Outcomes
Gut microbiota diversity and composition
Time Frame: baseline and 3-month
Fecal samples will be collected from study participants, and the diversity and 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.
10-year ASCVD risk assessed by the Pooled Cohort Equations
Time Frame: baseline, 3-month and 6-month
The Pooled Cohort Equations (PCE) will be utilized to estimate the 10-year risk of ASCVD. The required data will include age, gender, race, total cholesterol, HDL cholesterol, systolic blood pressure, hypertension treatment status, smoking status, and diabetes status. The PCE is a well-established and validated model for predicting ASCVD risk.
Secondary Outcomes
- Blood pressure(baseline, 3-month and 6-month)
- Waistline(baseline, 3-month and 6-month)
- Physical activity assessed by IPAQ(baseline, 3-month and 6-month)
- Liver function index(baseline, 3-month and 6-month)
- HIV specific ASCVD risk factors(baseline, 3-month and 6-month)
- Dietary Regimen Adherence Scale(baseline, 3-month and 6-month)
- Blood lipids(baseline and 3-month; 6-month only collect HDL-C, LDL-C, TC, and TG)
- BMI(baseline, 3-month and 6-month)
- SF-36 Abbreviated Quality of Life Scale(baseline, 3-month and 6-month)
- Food frequency questionnaire(baseline, 3-month)
- ASCVD related symptoms(baseline, 3-month and 6-month)
- Three-day dietary diary(baseline, 3-month and 6-month)
- Renal function index(baseline, 3-month and 6-month)
- Glucose(baseline, 3-month and 6-month)
- Inflammatory markers(baseline, 3-month)
Investigators
Junwen Yu
PhD candidate
Fudan University