Exploratory Study on a Multi-nutrient Supplement and Exercise Program for Improving Health Markers Associated to Longevity in Pre-frail Adults

Официальное название

A Single-arm Exploratory Study to Investigate the Feasibility to Develop a Composite Score That Encompasses Gut (Microbiome), Muscle, Immune, Cognition Outcomes Based on a 12-weeks Intervention of a Novel Multi-nutrient Supplement Containing Synbiotics, Combined With Supervised Exercise in Pre-frail Individuals Aged 50 - 80 Years Old.

Обзор

Frailty is associated with biological changes in the gut microbiome and immune system, along with marked declines in physical and cognitive function, leading to an overall reduction in quality of life. Prefrailty represents an early stage where interventions may prevent or reverse these declines. This study aims to evaluate whether a 12-week combined Synbiotic enriched oral nutritional supplement and supervised exercise program can improve muscle strength and mass, gut microbiome composition, immune function, and cognitive performance in prefrail adults aged 50-80 years.

Подробное описание

As we age, biological age, gut microbiome, muscle, immune, and cognition undergo gradual decline. Aging is associated with progressive declines in multiple physiological systems which affects healthspan (years free from diseases). Skeletal muscle undergoes atrophy and functional impairment, characterized by reductions in muscle fiber size and number. Cognitive decline occurs with age and is associated with structural and functional brain changes, contributing to impairments in memory, attention, and executive function. The aging immune system exhibits immuno-senescence, marked by diminished adaptive immune responses, altered T-cell function, and chronic low-grade inflammation. To reduce the healthspan-lifespan gap, Healthy Longevity Medicine (HLM) aims to optimise health and healthspan by targeting the ageing processes across the lifespan. To help mitigate these age-related changes, research is increasingly focused on developing targeted interventions such as nutritional supplements and structured exercise programs. Objective: To explore the effects of a 12-week intervention including supervised exercise and a Synbiotic enriched oral nutritional supplement on gut (microbiome), muscle, immune, cognition and biological age outcomes in pre-frail individuals aged 50-80 years. Study design: This is a single-arm, open-label, interventional, exploratory, single-centre study in which 40 pre-frail male and female individuals aged 50-80 years will be administered a novel multi-nutrient supplement containing synbiotics combined with supervised exercise for a total of 12 weeks.

Вмешательства

• Поведенческое Supervised exercise program
  A supervised exercise intervention consisting of resistance and endurance training, delivered two times per week, with each session lasting 60 minutes, conducted by an exercise physiologist in the gym's clinic in Singapore.
• Пищевая добавка a balanced micronutrient blend
  A balanced micronutrient blend containing soral nutritional supplement in powder form containing a synbiotic blend of prebiotics and probiotic, a protein blend and a micronutrient blend provided by Danone Global R\&I Center. The participant will be required to take two servings of the study product daily for 12 weeks.

Первичные конечные точки

• Change in muscle mass measured via B- mode ultrasound [Срок оценки: Baseline and 12 weeks]
• Change on Fecal Bifidobacterium level measured via stool microbiome analysis [Срок оценки: Baseline, 6 weeks and 12 weeks]

Вторичные конечные точки (12)

• Change in cognitive performance National Institutes of Health Toolbox Cognition Battery - Fluid composite [Срок оценки: Baseline and 12 weeks]
• Change in the immune function (CD4+: CD8+ ratio) [Срок оценки: Baseline, 6 weeks and 12 weeks]
• Change in cardiorespiratory fitness (Peak VO₂) [Срок оценки: Baseline and 12 weeks]
• Change in Muscle Strength assessed using 1RM strength test [Срок оценки: Baseline and 12 weeks]
• Change in Handgrip Strength Measured by Dynamometer [Срок оценки: Baseline, 6 weeks and 12 weeks]
• Stool consistency, frequency and gastrointestinal tolerance [Срок оценки: baseline, 12 weeks]
• Change in Biological age determined by DNAm clocks [Срок оценки: baseline, 12 weeks]
• Change in advanced glycation end-products (AGEs) assessed using skin autofluorescence. [Срок оценки: Baseline, 12 weeks]
• Change in inflammatory markers (IL-6, IL-10, TNF-α and IFN-γ) [Срок оценки: Baseline, 6 weeks and 12 weeks]
• Change in immune function as measured by Lymphocyte/neutrophil ratio [Срок оценки: Baseline, 6 weeks and 12 weeks]
• Change in blood pressure measured using SphygmoCor-XCEL [Срок оценки: baseline, 6 weeks, 12 weeks]
• Change in Arterial stiffness measured via SphygmoCor-XCEL [Срок оценки: Baseline and 12 weeks]

Критерии участия

Критерии включения

• Singapore residents of all ethnic groups
• Adults aged 50-80 years (both male and female)
• Body mass index (BMI) ≥18 kg/m²
• Classified as Prefrailty according to Fried frailty criteria
• Willing and able to attend all data collection visits and to comply with the exercise and supplementation protocols.
• Able and willing to provide written informed consent.

Критерии исключения

• Current use of supplements containing: Bifidobacterium longum 536 (BB536) like Kordel's BB536 bifidus; Bifidobacterium longum such as GniiB immunity; GOS (Galacto-oligosaccharides); FOS (Fructo-oligosaccharides); Inulin or any commercial healthy-aging powdered milk products
• BMI >30 kg/m2 3 Being on special diets including but not limited to ketogenic diets or diets prescribed by a healthcare professional

4\. Received any vaccination within the past 8 weeks. 5. Inition of new medication or use of medications affecting gastrointestinal function within the past 8 weeks, including but not limited to antibiotics or Proton pump inhibitors 6. Known allergies or intolerances, including, soy allergy; fibre allergy (e.g., GOS) or requirement for a fibre-free diet; fish allergy; Cow's milk protein allergy or lactose intolerance; galactosaemia 7. More than two unstable chronic conditions (e.g., hypertension, diabetes, hyperlipidemia, osteoarthritis, COPD) 8. Medical conditions for which probiotic use is contraindicated, including but not limited to immunocompromised individuals, astrointestinal failure or severe gastrointestinal disturbances (e.g., blood in stool), presence of a central venous catheter, open wounds following surgery 9. Contraindications to oral feeding, including gastrointestinal failure, complete intestinal obstruction, inability to access the gut or high loss intestinal fistulae 10. Known renal disease were unable to tolerate 2 servings per day. 11. Intake of supplemental calcium >500 mg/day or vitamin D >40 µg/day (1600 IU) from all sources, including diet and supplements 12. Use of medications that may interact with or impair absorption of milk products (e.g., tetracyclines) 13. Any other condition deemed by PI that may compromise participant safety and study compliance.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Сингапур · 1 центр

• MD11 Clinical Research Centre, #03-01, 10 Medical Drive — Singapore

Идентификаторы

NCT: NCT07454616 · NUS-IRB-2025-418

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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