NCT07454616

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

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National University of Singapore · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pre-Frailty
• Aging

Interventions

Type	Name	Description
BEHAVIORAL	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2025-09-22
• Primary completion: 2026-04-30
• Completion: 2026-05-08
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Singapore