Effectiveness of Gut Microbiota-targeted Diatery Intervention Among People Living With HIV
NCT Number: NCT06498401
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV|Atherosclerosis|Diet, Healthy
Interventions: DIETARY_SUPPLEMENT: gut microbiota-targeted dietary intervention
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-20
Completion Date: 2025-04-30

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.

Primary Outcome Measures: ASCVD prediction risk, 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., baseline, 3-month and 6-month|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., baseline and 3-month
Secondary Outcome Measures: Blood lipids, HDL-C, LDL-C, TC, TG, ApoA1, ApoB, Lp(a), and CRP, baseline, 3-month and 6-month|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., baseline, 3-month and 6-month|BMI, To calculate BMI, the weight in kilograms is divided by the square of the height in meters (BMI = weight(kg) / height(m)\^2)., baseline, 3-month and 6-month|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. The result is accurate to 1 centimeter., baseline, 3-month and 6-month|Hip circumference, The measurement was done horizontally around the greater trochanter of the femur. The result is accurate to 1 centimeter., baseline, 3-month and 6-month|ASCVD related symptoms, Use the ACS symptom checklist and Memorial symptom assessment scale-heart failure to estimate ASCVD-related symptoms. The ACS Symptom Checklist is a validated instrument comprising 13 items designed to assess symptoms associated with ACS. Participants are asked to indicate whether each symptom is present (1) or absent (0). Each symptom is analyzed individually, and there is no composite score. The Memorial Symptom Assessment Scale-Heart Failure comprises 32 items, categorized into three subscales: physiological symptoms (n=21), psychological symptoms (n=6), and heart failure symptoms (n=5). Symptoms are rated on presence, frequency, severity, and distress, with frequency, severity, and distress rated on a Likert scale of 1-4, where higher scores indicate higher frequency, severity or greater distress., baseline, 3-month and 6-month|Three-day dietary diary, Write down the food and drink the participants have in two working days and one rest day., baseline, 3-month and 6-month|SF-36 Abbreviated Quality of Life Scale, The scale was developed by the Boston Health Research Institute, based on the Rand Corporation Health Insurance project, to assess the degree of health change in the past year. In 1996, the International Quality of Life Evaluation Organization recommended the use of SF-36 for quality of life measurement. There are 36 items in the scale, of which item 2 is self-reported health change and does not participate in the score calculation of the scale. The remaining 35 entries are divided into eight dimensions, Including physical functioning, role-physical, bodily pain, and general health perceptions, vitality, social functioning, role-emotional, and mental health. The higher the score of each item, the better the quality of life., baseline, 3-month and 6-month|Physical activity, The international physical activity questionnaire (IPAQ) is a standardized tool for assessing an individual's physical activity level, originally developed by international organizations such as the World Health Organization and the U.S. Centers for Disease Control and Prevention. Available in short and long versions, it has been validated in more than 12 countries. The short version of the IPAQ consists of seven questions that assess an individual's level of physical activity by calculating total energy expended per week (MET-minutes/week)., baseline, 3-month and 6-month|Renal function index, Cr and BUN, baseline, 3-month and 6-month|Liver function index, total protein, albumin, globulin, white/ball ratio, total bilirubin, directly bound bilirubin, indirect bilirubin, total bile acid, alanine aminotransferase, aspartate aminotransferase, AST/ALT, and gamma-glutamyltransferase, baseline, 3-month and 6-month|Glucose, Measurement of blood glucose levels., baseline, 3-month and 6-month|Inflammatory markers, IL-6, IL-8, IL-1β, TNF-a, baseline, 3-month|HIV specific ASCVD risk factors, HIV RNA, CD4 count, CD8 count, baseline, 3-month and 6-month|Dietary Regimen Adherence Scale (adapted from Mediterranean item 14), Adapted from the 14-item Mediterranean diet adherence screener (MEDAS), which contains two questions about eating habits and eight questions about the frequency of consumption of typical foods in this dietary regimen, And 4 questions about foods not recommended in this diet. Each question is scored on the scale of compliance (1) or non-compliance (0)., baseline, 3-month and 6-month|Food frequency questionnaire, Food frequency Questionnaire (FFQ 146) is from the complete food frequency questionnaire used by the National Institute of Nutrition and Food Safety of the Chinese Center for Disease Control and Prevention in a dietary survey in Beijing Exhibition Road community, including 146 food items., baseline, 3-month and 6-month