An interventional study of dietary intervention in Hiv, Atherosclerosis and Diet, Healthy, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Fudan University · Not applicable, Interventional, and Prevention
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 older people living with HIV (PLWH).
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 CVD risk 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.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's planned enrollment of 110 is close to the median of 106 across 882 interventional studies indexed under Atherosclerosis.
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Exclusion Criteria:
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
Other: dietary intervention
The control group will continue routine follow-up and health education practices.
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.
10-year ASCVD risk assessed by the Pooled Cohort Equations
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.
Time frame: 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. Diversity Analysis: Bacterial richness and phylogenetic diversity within samples will be assessed using Faith's Phylogenetic Diversity and richness metrics. Taxonomic Composition: Relative abundance of specific bacterial taxa will be determined.
Time frame: baseline and 3-month
Blood lipids
HDL-C, LDL-C, TC, TG, ApoA1, ApoB, Lp(a), and CR
Time frame: baseline and 3-month; 6-month only collect HDL-C, LDL-C, TC, and TG
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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: baseline, 3-month and 6-month
Physical activity assessed by IPAQ
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).
Time frame: baseline, 3-month and 6-month
Renal function index
Cr and BUN
Time frame: 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
Time frame: baseline, 3-month and 6-month
Glucose
Measurement of blood glucose levels
Time frame: baseline, 3-month and 6-month
Inflammatory markers
IL-6, IL-8, TNF-a
Time frame: baseline, 3-month
HIV specific ASCVD risk factors
HIV RNA, CD4 count, CD8 count
Time frame: baseline, 3-month and 6-month
Dietary Regimen Adherence Scale
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)
Time frame: 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
Time frame: baseline, 3-month
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