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

Effectiveness of Gut Microbiota-targeted Diatery Intervention in Preventing Atherosclerotic Cardiovascular Disease Among People Living With HIV

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atherosclerosis; HIV; Diet, Healthy
• Intervention / Treatment: Dietary supplement: gut microbiota-targeted dietary intervention

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; The control group will continue routine follow-up and health education practices.
Experimental: intervention group; 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.	Dietary supplement: gut microbiota-targeted dietary intervention; The dietary intervention targeted at gut microbiota. Each participant's dietary habits,food preferences and economic level were taken into account. The dietary intervention was delivered by sending meals. To ensure the freshness and quality of the ingredients, 2 dedicated researchers were jointly responsible for the procurement of fresh ingredients, which were purchased through regular channels on Monday, Wednesday and Friday mornings. Meals will be delivered three times a week for a 12-week intervention period. Guided dietary follow-up was conducted through WeChat or telephone follow-up. The researcher will provide cooking instruction or dietary pattern guidance every two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: SZ2024-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No