iVS-1 Probiotic Intervention Targeting Biological Aging in Midlife Adults
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: Bifidobacterium adolescentis iVS-1, Placebo.
- Кому может быть актуально
- Состояния в реестре: Healthy Aging, Anti Aging. Базовые параметры: 40 лет — 75 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
VITAL-Age Trial (iVS-1 Investigation for Targeting Aging and Longevity)
Обзор
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of Bifidobacterium adolescentis (iVS-1) supplementation on biological aging markers, metabolic health, and functional health outcomes in midlife adults. The study explores whether modulation of aging-related biological pathways through the gut microbiome may influence health-related outcomes.
Подробное описание
Aging is associated with progressive physiological changes involving inflammation, cellular senescence, mitochondrial function, and alterations in the gut microbiome. Interventions targeting these biological processes may influence age-related health outcomes. The gut microbiome plays a central and modifiable role, influencing metabolic health, inflammation, neurocognitive outcomes, and systemic aging processes.
Reductions in Bifidobacterium adolescentis have been observed with aging and have been associated with metabolic and inflammatory changes. Preliminary studies suggest that supplementation with this species may affect biological pathways relevant to aging.
This study is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of Bifidobacterium adolescentis (iVS-1) supplementation in adults aged 40-75 years. Participants will be randomized to receive iVS-1 (≥8 billion CFU per capsule) or placebo once daily for 150 days. Blood- and stool-based assessments and questionnaires about cognition, sleep quality, and quality of life will be collected at baseline, mid-intervention, and end of study.
Changes in these measures will be used to assess the relationship between Bifidobacterium adolescentis iVS-1 supplementation and biological aging markers, metabolic health, and functional health outcomes.
Вмешательства
- Пищевая добавка Bifidobacterium adolescentis iVS-1
B. adolescentis iVS-1 (probiotic capsule) delivered orally once daily at a minimum of 8 billion CFU/day - Пищевая добавка Placebo
Placebo capsule delivered orally once daily
Первичные конечные точки
- Change in Biological Aging Biomarkers [Срок оценки: Baseline to Day 150]
Вторичные конечные точки (7)
- Change in Phenotypic Age [Срок оценки: Baseline to Day 150]
- Change in Bifidobacterium adolescentis iVS-1 Abundance [Срок оценки: Baseline to Day 150]
- Change in Metabolic Health [Срок оценки: Baseline to Day 150]
- Change in Lipid Profiles [Срок оценки: Baseline to Day 150]
- Change in Cognitive Function [Срок оценки: Baseline to Day 150]
- Change in Sleep Quality [Срок оценки: Baseline to Day 150]
- Change in Quality of Life [Срок оценки: Baseline to Day 150]
Критерии участия
Критерии включения
- Aged 40-75 years.
- BMI: 20-34.9 kg/m².
- Able and willing to sign informed consent and participate for the study duration.
Критерии исключения
- Chronic disease history (liver, kidney, heart).
- Current pregnancy and/or lactating.
- Colonoscopy and/or its preparation within 4 weeks of screening.
- Those who intend to have children during study period.
- Current probiotic, prebiotics and/or metabolic-altering supplement use.
- Those who are unable to cooperate with investigators and testing.
- Known history of cancer and/or ongoing cancer treatments.
- Abuse of drugs, alcohol, tobacco, nicotine and other substances.
- History of cardiac diseases: atherosclerosis, heart failure, unstable angina, stable angina, etc., and chronic hypoxic disease: emphysema, pulmonary heart disease and others related.
- History of chronic and major GI disease (pancreatitis, IBS, and IBD) and intestinal surgeries.
- Type 1 or 2 diabetes mellitus.
- Poorly controlled chronic diseases (hypertension, hyperlipidemia) that are clinically unstable.
- Vulnerable groups, including clinically ill, mentally ill, cognitively impaired, minors, and illiterate etc.
- Significant weight loss (>20%) in prior one month.
- Conditions affecting safety or outcome integrity.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Фундаментальное исследование
Центры проведения
США · 1 центр
- MusB Research LLC — New Port Richey
Идентификаторы
NCT: NCT07407894 · MB-VITAL