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.
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 older people living with HIV (PLWH).
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
10-year ASCVD risk assessed by the Pooled Cohort Equations — 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.
Gut microbiota diversity and composition — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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