Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06560840

Effectiveness of Gut Microbiota-targeted Diatery Intervention Among Older 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 older people living with HIV (PLWH).

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines;
  • Aged 40 years and above;
  • at risk of CVD: having any two of those risk factors: dyslipidemia, DM or elevated blood glucose, smoking, hypertention or elevated blood pressure, metabolic syndrome,overweight/obesity; or PCE score>5%,
  • 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

Exclusion criteria

  • 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, 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.

Treatment and study plan

Dietary Intervention

Other

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.

Primary outcomes

  1. 10-year ASCVD risk assessed by the Pooled Cohort Equations

    Time frame: 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.

  2. Gut microbiota diversity and composition

    Time frame: 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. 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.

Secondary outcomes

  1. Blood lipids

    Time frame: baseline and 3-month; 6-month only collect HDL-C, LDL-C, TC, and TG

    HDL-C, LDL-C, TC, TG, ApoA1, ApoB, Lp(a), and CR

  2. Blood pressure

    Time frame: 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.

  3. BMI

    Time frame: 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).

  4. Waistline

    Time frame: 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.

  5. ASCVD related symptoms

    Time frame: 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).

  6. Three-day dietary diary

    Time frame: baseline, 3-month and 6-month

    Write down the food and drink the participants have in two working days and one rest day.

  7. SF-36 Abbreviated Quality of Life Scale

    Time frame: 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.

  8. Physical activity assessed by IPAQ

    Time frame: 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).

  9. Renal function index

    Time frame: baseline, 3-month and 6-month

    Cr and BUN

  10. Liver function index

    Time frame: 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

  11. Glucose

    Time frame: baseline, 3-month and 6-month

    Measurement of blood glucose levels

  12. Inflammatory markers

    Time frame: baseline, 3-month

    IL-6, IL-8, TNF-a

  13. HIV specific ASCVD risk factors

    Time frame: baseline, 3-month and 6-month

    HIV RNA, CD4 count, CD8 count

  14. Dietary Regimen Adherence Scale

    Time frame: 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)

  15. Food frequency questionnaire

    Time frame: baseline, 3-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

Study contacts

Contact information is provided by the study sponsor or research team.

Junwen Yu, Dr

CONTACT

[email protected]

13320178333

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.