HivNCT06279819
Effectiveness of Gut Microbiota-targeted Dietary Intervention Among HIV-infected Patients
A study testing gut microbiota-targeted dietary intervention in people with Hiv and Cardiovascular Diseases, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Cardiovascular Diseases, Diet, Healthy
- What is being tested?
- gut microbiota-targeted dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines (2021 edition);
- Aged 18 years and above;
- PCE predicted ASCVD risk of 5% - <7.5%;
- 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.
Who cannot join
- Those with a past history of CVD;
- Those with HIV-related neurocognitive disorders and various serious opportunistic infections;
- Those with diabetes mellitus;
- Known nut allergy;
- Planning to become pregnant within 6 months;
- Are on lipid-lowering therapy or using any interfering medications or diets;
- Are participating in other HIV-related or dietary intervention-related scientific research programs.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University
Shanghai, Shanghai Municipality, 200032
Junwen Yu, 13320178333, 13320178333@163.com
About this study
Official title: Effectiveness of Gut Microbiota-targeted Dietary Intervention in Preventing Borderline Atherosclerotic Cardiovascular Disease Risk Among HIV-infected Patients
The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are:
- Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease.
- Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients.
- Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease.
Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos 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.
Read the detailed description
Methods and data:
- Mendelian randomization A two-step, two-sample mendelian randomization will be employed to investigate the potential mediating roles of gut microbiota in the causal relationship between HIV and atherosclerotic cardiovascular disease. Utilizing GWAS summary statistics from the Medical Research Council Integrative Epidemiology Unit OpenGWAS data and the MiBioGen study, we will conduct univariable mendelian randomization. The first step involves examining the causal pathway of HIV infection on gut microbiota (the coefficient=α), followed by elucidating the influence of gut microbiota on the development of atherosclerotic cardiovascular disease (the coefficient=β). The multiplication of these estimates (α*β) will delineate the mediation effects attributed to gut microbiota. Identification of specific gut microbiota exhibiting substantial mediation effects will guide the selection of our targeted intervention.
- Systematic review To establish an empirical research foundation, a systematic review will synthesize evidence concerning the correlation between dietary patterns and gut microbiota, as well as the relationship between microbiota and atherosclerotic cardiovascular disease among people living with HIV. A thorough systematic search across database including PubMed/MEDLINE, MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCO), Web of Science, and China National Knowledge Infrastructure (CNKI). Articles meeting predefined inclusion and exclusion criteria will undergo rigorous extraction and summarization processes.
- Intervention design and expert evaluation The intervention protocol will be formulated, drawing from the gut microbiota identified demonstrating significant mediation effects in the causal association between HIV infection and atherosclerotic cardiovascular disease, along with insights gleaned from the systematic review. Subsequently, multidisciplinary experts will be invited to evaluate the drafted protocol using the FAME (Feasibility, Appropriateness, Meaningfulness and Effectiveness) scale developed by the Joanna Briggs Institute.
- Pragmatic randomized controlled trial We 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 risk of atherosclerotic cardiovascular disease (5% to <7.5%) 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 health education videos 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 atherosclerotic cardiovascular disease 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.
- Conditions
- Hiv, Cardiovascular Diseases, Diet, Healthy
- Being tested
- gut microbiota-targeted dietary intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gut microbiota-targeted dietary interventionDietary supplement
The dietary intervention used the dietary intervention plan constructed in Phase 2, on the basis of which each study participant's individual dietary habits, food preferences and economic level were taken into account.
The dietary intervention was delivered by sending fresh ingredients. 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.
Ingredients will be delivered three times a week for a 12-week intervention period. The initial food items to be sent include: 90g of fish rich in omega-3 fatty acids; 300g of vegetables and/or legumes, and 200g of fruits; 30g of nuts; and a cup of probiotic yogurt.
Guided dietary follow-up was conducted through video viewing and WeChat or telephone follow-up. The researcher will provide cooking instruction or dietary pattern guidance by sending videos every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. The intervention will span three months, followed by a three-month follow-up period. Receives: Dietary Supplement: gut microbiota-targeted dietary intervention |
| control group | No intervention | The control group will continue routine follow-up and health education practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASCVD risk estimated by the PCE
Use the pooled cohort equation to estimate the participants' 10-year ASCVD risks
Measured: baseline, 3-month and 6-month
The composition of gut microbiota
Fecal samples will be collected from study participants, and the 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 through statistical analyses performed using phyloseq v. 1.26 and ggplot2 v. 3. Differential Abundance: A differential abundance analysis of Operational Taxonomic Units will be conducted. Beta Diversity: Differences in gut bacterial patterns among subjects consuming different diets will be evaluated using Bray Curtis dissimilarity, Weighted UniFrac, and Unweighted UniFrac metrics. Multivariate Analysis: Principal Coordinates Analysis will be performed to assess variations in the microbiome associated with dietary interventions.
Measured: baseline and 3-month
Secondary outcomes (4)
fasting blood lipids
Fasting venous blood will be collected by venepuncture and centrifuged (4 C, 4000 rpm, 10 min) before plasma and erythrocytes are separately aliquoted and frozen at -20 ℃ and then stored at -80 ℃. Automated biochemical analyzer will be used to test the HDL-C (mmol/L), LDL-C (mmol/L), TG (mmol/L), and TC (mmol/L).
Measured: baseline, 3-month and 6-month
blood pressure
To measure blood pressure using the Omron automatic blood pressure monitor, first ensure the patient is relaxed and seated comfortably with their back supported and feet flat on the floor. Place the cuff around the upper arm at heart level, ensuring a snug fit without being too tight. Use the device's inflation bulb to gradually inflate the cuff until it's sufficiently tight to stop blood flow, then slowly deflate the cuff while listening for the heartbeat sounds using the device's sensor. 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.
Measured: baseline, 3-month and 6-month
BMI
To measure BMI (Body Mass Index), first, the individual's height and weight are required. The person should be barefoot and wearing light clothing. Using a calibrated scale, the person's weight is measured in kilograms (kg). Next, their height is measured in meters (m) using a stadiometer or similar device. To calculate BMI, the weight in kilograms is divided by the square of the height in meters (BMI = weight(kg) / height(m)^2).
Measured: baseline, 3-month and 6-month
ASCVD 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.
Measured: baseline, 3-month and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junwen Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279819
- Sponsor's protocol ID
- 2024-008
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Gut Microbiota-targeted Dietary Intervention in Preventing Borderline Atherosclerotic Cardiovascular Disease Risk Among HIV-infected Patients
- ClinicalTrials.gov ID
- NCT06279819
- Acronym / sponsor ID
- 2024-008
- Conditions
- Hiv, Cardiovascular Diseases, Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are:
- Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease.
- Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients.
- Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease.
Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos 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
Methods and data:
- Mendelian randomization A two-step, two-sample mendelian randomization will be employed to investigate the potential mediating roles of gut microbiota in the causal relationship between HIV and atherosclerotic cardiovascular disease. Utilizing GWAS summary statistics from the Medical Research Council Integrative Epidemiology Unit OpenGWAS data and the MiBioGen study, we will conduct univariable mendelian randomization. The first step involves examining the causal pathway of HIV infection on gut microbiota (the coefficient=α), followed by elucidating the influence of gut microbiota on the development of atherosclerotic cardiovascular disease (the coefficient=β). The multiplication of these estimates (α*β) will delineate the mediation effects attributed to gut microbiota. Identification of specific gut microbiota exhibiting substantial mediation effects will guide the selection of our targeted intervention.
- Systematic review To establish an empirical research foundation, a systematic review will synthesize evidence concerning the correlation between dietary patterns and gut microbiota, as well as the relationship between microbiota and atherosclerotic cardiovascular disease among people living with HIV. A thorough systematic search across database including PubMed/MEDLINE, MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCO), Web of Science, and China National Knowledge Infrastructure (CNKI). Articles meeting predefined inclusion and exclusion criteria will undergo rigorous extraction and summarization processes.
- Intervention design and expert evaluation The intervention protocol will be formulated, drawing from the gut microbiota identified demonstrating significant mediation effects in the causal association between HIV infection and atherosclerotic cardiovascular disease, along with insights gleaned from the systematic review. Subsequently, multidisciplinary experts will be invited to evaluate the drafted protocol using the FAME (Feasibility, Appropriateness, Meaningfulness and Effectiveness) scale developed by the Joanna Briggs Institute.
- Pragmatic randomized controlled trial We 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 risk of atherosclerotic cardiovascular disease (5% to <7.5%) 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 health education videos 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 atherosclerotic cardiovascular disease 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Dietary Supplement: gut microbiota-targeted dietary interventionThe intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. The intervention will span three months, followed by a three-month follow-up period. |
| control group | No intervention | –The control group will continue routine follow-up and health education practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines (2021 edition);
- Aged 18 years and above;
- PCE predicted ASCVD risk of 5% - <7.5%;
- Those with a predicted survival time of >1 year;
- No plans to leave the depth in the next 3 months;
Key exclusion criteria (7 listed)
- Those with a past history of CVD;
- Those with HIV-related neurocognitive disorders and various serious opportunistic infections;
- Those with diabetes mellitus;
- Known nut allergy;
- Planning to become pregnant within 6 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gut microbiota-targeted dietary interventionThe dietary intervention used the dietary intervention plan constructed in Phase 2, on the basis of which each study participant's individual dietary habits, food preferences and economic level were taken into account. The dietary intervention was delivered by sending fresh ingredients. 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. Ingredients will be delivered three times a week for a 12-week intervention period. The initial food items to be sent include: 90g of fish rich in omega-3 fatty acids; 300g of vegetables and/or legumes, and 200g of fruits; 30g of nuts; and a cup of probiotic yogurt. Guided dietary follow-up was conducted through video viewing and WeChat or telephone follow-up. The researcher will provide cooking instruction or dietary pattern guidance by sending videos every two weeks. | Dietary supplement | intervention group |
Primary outcome
ASCVD risk estimated by the PCE
Time frame: baseline, 3-month and 6-month
Use the pooled cohort equation to estimate the participants' 10-year ASCVD risks
The composition of gut microbiota
Time frame: baseline and 3-month
Fecal samples will be collected from study participants, and the 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 through statistical analyses performed using phyloseq v. 1.26 and ggplot2 v. 3. Differential Abundance: A differential abundance analysis of Operational Taxonomic Units will be conducted. Beta Diversity: Differences in gut bacterial patterns among subjects consuming different diets will be evaluated using Bray Curtis dissimilarity, Weighted UniFrac, and Unweighted UniFrac metrics. Multivariate Analysis: Principal Coordinates Analysis will be performed to assess variations in the microbiome associated with dietary interventions.
4 secondary outcomes
fasting blood lipids
Time frame: baseline, 3-month and 6-month
blood pressure
Time frame: baseline, 3-month and 6-month
BMI
Time frame: baseline, 3-month and 6-month
ASCVD symptoms
Time frame: baseline, 3-month and 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gut microbiota-targeted dietary intervention in people with Hiv and Cardiovascular Diseases, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASCVD risk estimated by the PCE (time frame: baseline, 3-month and 6-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.