Clinical trial NCT06498401: Effectiveness of Gut Microbiota-targeted Diatery Intervention Among People Living With HIV
Official title: Effectiveness of Gut Microbiota-targeted Diatery Intervention in Preventing Atherosclerotic Cardiovascular Disease Among People Living With HIV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Atherosclerosis
Diet, Healthy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
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 people living with HIV (PLWH).

Participants in 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.

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 a borderline or medium risk of atherosclerotic cardiovascular disease (5% to \<20%) determined by the pooled cohort equation, 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 18 years and above;
3. PCE predicted ASCVD risk of 5% - \<20%;
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, kidney diseases, 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: ASCVD prediction risk
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, 3-month and 6-month
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: Hip circumference
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
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 (adapted from Mediterranean item 14)
timeFrame: baseline, 3-month and 6-month
measure: Food frequency questionnaire
timeFrame: baseline, 3-month and 6-month
Other outcomes:
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