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

NCT06560840 | Recruiting

• 1 other identifier: SZ-2024-008
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hiv; Atherosclerosis; Diet, Healthy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline and 3-month

Secondary Outcomes (15)

• Blood lipids

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

• Blood pressure

  baseline, 3-month and 6-month

• BMI

  baseline, 3-month and 6-month

• Waistline

  baseline, 3-month and 6-month

• ASCVD related symptoms

  baseline, 3-month and 6-month

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

The control group will continue routine follow-up and health education practices.

Interventions

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.

intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

The Third People's Hospital of Shenzhen

Shenzhen, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Atherosclerosis

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Hongzhou Lu, Dr

  Shenzhen Third People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Junwen Yu, Dr

CONTACT

13320178333; 13320178333@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: August 20, 2024
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)