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Recruiting NCT06560840

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

No phase Interventional Hiv Atherosclerosis Diet, Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dietary intervention.
Who it may be relevant to
Registry conditions: Hiv, Atherosclerosis, Diet, Healthy. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

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 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.

Interventions

  • Other 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 int

Primary outcome measures

  • 10-year ASCVD risk assessed by the Pooled Cohort Equations [Time frame: baseline, 3-month and 6-month]
  • Gut microbiota diversity and composition [Time frame: baseline and 3-month]
Secondary outcome measures (12)
  • Blood lipids [Time frame: baseline and 3-month; 6-month only collect HDL-C, LDL-C, TC, and TG]
  • Blood pressure [Time frame: baseline, 3-month and 6-month]
  • BMI [Time frame: baseline, 3-month and 6-month]
  • Waistline [Time frame: baseline, 3-month and 6-month]
  • ASCVD related symptoms [Time frame: baseline, 3-month and 6-month]
  • Three-day dietary diary [Time frame: baseline, 3-month and 6-month]
  • SF-36 Abbreviated Quality of Life Scale [Time frame: baseline, 3-month and 6-month]
  • Physical activity assessed by IPAQ [Time frame: baseline, 3-month and 6-month]
  • Renal function index [Time frame: baseline, 3-month and 6-month]
  • Liver function index [Time frame: baseline, 3-month and 6-month]
  • Glucose [Time frame: baseline, 3-month and 6-month]
  • Inflammatory markers [Time frame: baseline, 3-month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

China · 1 center
  • The Third People's Hospital of Shenzhen — Shenzhen

Identifiers

NCT: NCT06560840 · SZ-2024-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗