Effectiveness of Gut Microbiota-targeted Diatery Intervention in Preventing Atherosclerotic Cardiovascular Disease Among People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- ASCVD prediction risk
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines;
- •Aged 18 years and above;
- •PCE predicted ASCVD risk of 5% - <20%;
- •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.
排除标准
- •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, kidney diseases, 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.
结局指标
主要结局
ASCVD prediction risk
时间窗: 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
时间窗: 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.
次要结局
- Renal function index(baseline, 3-month and 6-month)
- ASCVD related symptoms(baseline, 3-month and 6-month)
- BMI(baseline, 3-month and 6-month)
- Physical activity(baseline, 3-month and 6-month)
- Inflammatory markers(baseline, 3-month)
- Blood lipids(baseline, 3-month and 6-month)
- Waistline(baseline, 3-month and 6-month)
- Hip circumference(baseline, 3-month and 6-month)
- Dietary Regimen Adherence Scale (adapted from Mediterranean item 14)(baseline, 3-month and 6-month)
- Blood pressure(baseline, 3-month and 6-month)
- SF-36 Abbreviated Quality of Life Scale(baseline, 3-month and 6-month)
- Liver function index(baseline, 3-month and 6-month)
- Glucose(baseline, 3-month and 6-month)
- HIV specific ASCVD risk factors(baseline, 3-month and 6-month)
- Three-day dietary diary(baseline, 3-month and 6-month)
- Food frequency questionnaire(baseline, 3-month and 6-month)