Effectiveness of Gut Microbiota-targeted Diatery Intervention Among Older People Living With HIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorFudan University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
dietary intervention
Other interventionThe 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: intervention groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
10-year ASCVD risk assessed by the Pooled Cohort Equations
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.
Time frame
baseline, 3-month and 6-month2
Gut microbiota diversity and composition
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.
Time frame
baseline and 3-monthSecondary outcomes
1
Blood lipids
HDL-C, LDL-C, TC, TG, ApoA1, ApoB, Lp(a), and CR
Time frame
baseline and 3-month; 6-month only collect HDL-C, LDL-C, TC, and TG2
Blood pressure
Using the Omron automatic blood pressure monitor. Record the values displayed on the monitor for both systolic and diastolic pressures (mmHg). Repeat this process three times with a short rest period between each measurement, and calculate the average of the three readings for accurate results.
Time frame
baseline, 3-month and 6-month3
BMI
To calculate BMI, the weight in kilograms is divided by the square of the height in meters (BMI = weight(kg) / height(m\^2).
Time frame
baseline, 3-month and 6-month4
Waistline
The measuring position is at the midpoint of the line between the anterior superior iliac ridge and the lower margin of the 12th rib. The tape is pressed against the skin, but it cannot be compressed.
Time frame
baseline, 3-month and 6-monthSponsors and contacts
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Source ClinicalTrials.gov