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Идёт набор NCT06560840

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

Без фазы С лечением Hiv Atherosclerosis Diet, Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: dietary intervention.
Кому может быть актуально
Состояния в реестре: Hiv, Atherosclerosis, Diet, Healthy. Базовые параметры: от 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

  • Другое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • The Third People's Hospital of Shenzhen — Шэньчжэнь

Идентификаторы

NCT: NCT06560840 · SZ-2024-008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗