Clinical trial NCT06560840: Effectiveness of Gut Microbiota-targeted Diatery Intervention Among Older People Living With HIV
Official title: Effectiveness of Gut Microbiota-targeted Diatery Intervention in Preventing Atherosclerotic Cardiovascular Disease Among Older People Living With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Atherosclerosis
Diet, Healthy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 outcomes:
measure: 10-year ASCVD risk assessed by the Pooled Cohort Equations
timeFrame: baseline, 3-month and 6-month
measure: Gut microbiota diversity and composition
timeFrame: baseline and 3-month
Secondary outcomes:
measure: Blood lipids
timeFrame: baseline and 3-month; 6-month only collect HDL-C, LDL-C, TC, and TG
measure: Blood pressure
timeFrame: baseline, 3-month and 6-month
measure: BMI
timeFrame: baseline, 3-month and 6-month
measure: Waistline
timeFrame: baseline, 3-month and 6-month
measure: ASCVD related symptoms
timeFrame: baseline, 3-month and 6-month
measure: Three-day dietary diary
timeFrame: baseline, 3-month and 6-month
measure: SF-36 Abbreviated Quality of Life Scale
timeFrame: baseline, 3-month and 6-month
measure: Physical activity assessed by IPAQ
timeFrame: baseline, 3-month and 6-month
measure: Renal function index
timeFrame: baseline, 3-month and 6-month
measure: Liver function index
timeFrame: baseline, 3-month and 6-month
measure: Glucose
timeFrame: baseline, 3-month and 6-month
measure: Inflammatory markers
timeFrame: baseline, 3-month
measure: HIV specific ASCVD risk factors
timeFrame: baseline, 3-month and 6-month
measure: Dietary Regimen Adherence Scale
timeFrame: baseline, 3-month and 6-month
measure: Food frequency questionnaire
timeFrame: baseline, 3-month
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: The Third People's Hospital of Shenzhen
Study officials:
affiliation: Shenzhen Third People's Hospital
name: Hongzhou Lu, Dr
role: STUDY_DIRECTOR
References: