Effectiveness of Gut Microbiota-targeted Diatery Intervention Among People Living With HIV

Not Applicable

Not yet recruiting

• Conditions: HIV; Atherosclerosis; Diet, Healthy
• Interventions: Dietary Supplement: gut microbiota-targeted dietary intervention

• Registration Number: NCT06498401
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Study Start: 2024-07-20
• Primary Completion: 2025-01-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	gut microbiota-targeted dietary intervention	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. The intervention will span three months, followed by a three-month follow up period.

Primary Outcome Measures

Name	Time	Method
ASCVD prediction risk	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	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.

Secondary Outcome Measures

Name	Time	Method
ASCVD related symptoms	baseline, 3-month and 6-month	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.
BMI	baseline, 3-month and 6-month	To calculate BMI, the weight in kilograms is divided by the square of the height in meters (BMI = weight(kg) / height(m)\^2).
Physical activity	baseline, 3-month and 6-month	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).
Inflammatory markers	baseline, 3-month	IL-6, IL-8, IL-1β, TNF-a
Blood lipids	baseline, 3-month and 6-month	HDL-C, LDL-C, TC, TG, ApoA1, ApoB, Lp(a), and CRP
Renal function index	baseline, 3-month and 6-month	Cr and BUN
Waistline	baseline, 3-month and 6-month	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.
Hip circumference	baseline, 3-month and 6-month	The measurement was done horizontally around the greater trochanter of the femur. The result is accurate to 1 centimeter.
Dietary Regimen Adherence Scale (adapted from Mediterranean item 14)	baseline, 3-month and 6-month	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).
Blood pressure	baseline, 3-month and 6-month	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.
SF-36 Abbreviated Quality of Life Scale	baseline, 3-month and 6-month	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.
Liver function index	baseline, 3-month and 6-month	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
Glucose	baseline, 3-month and 6-month	Measurement of blood glucose levels.
HIV specific ASCVD risk factors	baseline, 3-month and 6-month	HIV RNA, CD4 count, CD8 count
Three-day dietary diary	baseline, 3-month and 6-month	Write down the food and drink the participants have in two working days and one rest day.
Food frequency questionnaire	baseline, 3-month and 6-month	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.