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.
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
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
Single group
Supervised exercise program
BehavioralA 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.
a balanced micronutrient blend
Dietary supplementA 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.
Change in muscle mass measured via B- mode ultrasound
Change from baseline to Week 12 in muscle mass assessed by muscle thickness measured using B-mode ultrasound. Muscle thickness was measured in centimeters (cm) at a predefined anatomical site
Change on Fecal Bifidobacterium level measured via stool microbiome analysis
Change from baseline at 6 and 12 weeks in stool Bifidobacterium abundance, measured by quantitative PCR (qPCR), and in microbiome diversity, measured by 16S rRNA gene sequencing and shotgun metagenomic sequencing.
Change in cognitive performance National Institutes of Health Toolbox Cognition Battery - Fluid composite
Change from baseline to 12 weeks in cognitive performance assessed by the National Institutes of Health Toolbox Cognition Battery - Fluid composite. \[scores of 0 to 100 in raw or age-corrected scaled score\]
Change in the immune function (CD4+: CD8+ ratio)
Change from baseline at 6 weeks and 12 weeks in CD4+: CD8+ in T-cell ratio
Change in cardiorespiratory fitness (Peak VO₂)
Change from baseline to 12 weeks in maximal oxygen uptake (VO₂peak) assessed using standardized cardiopulmonary exercise testing (mL/kg/min)
Change in Muscle Strength assessed using 1RM strength test
Change from baseline to 12 weeks in 1RM strength (Smith machine bench press) (Kg)
Study participation and retention rates
Participation rate defined as the percentage of eligible participants enrolled, and dropout rate defined as the percentage of participants who discontinue the study and reasons for dropout
Adherence to supplement intervention
Supplement adherence, measured as the proportion (%) and total number of prescribed doses taken, as verified by returned empty sachet counts at each visit.
Adherence to exercise intervention
Adherence to the exercise intervention, assessed as the number and percentage of scheduled exercise sessions attended, as recorded by study staff.
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National University of Singapore
Lead sponsor
Danone Global Research & Innovation Center
Collaborator
