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RECRUITING

NCT07454616

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

Sponsor: National University of Singapore

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-22

Completion Date

2026-05-08

Last Updated

2026-03-06

Healthy Volunteers

Conditions

Pre-Frailty Aging

Interventions

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.

Inclusion Criteria 1. Singapore residents of all ethnic groups 2. Adults aged 50-80 years (both male and female) 3. Body mass index (BMI) ≥18 kg/m² 4. Classified as Prefrailty according to Fried frailty criteria 5. Willing and able to attend all data collection visits and to comply with the exercise and supplementation protocols. 6. Able and willing to provide written informed consent. Exclusion Criteria: 1. 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 2. 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.

Locations (1)

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

Singapore, Singapore