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

NCT07454616 | Recruiting

• 1 other identifier: NUS-IRB-2025-418
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-Frailty; Aging

Keywords

Prefrail elderly; Gut microbiome; Nutritional supplementation; supervised exercise; Biological age markers

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline and 12 weeks

• 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.

  Baseline, 6 weeks and 12 weeks

Secondary Outcomes (21)

• Change in cognitive performance National Institutes of Health Toolbox Cognition Battery - Fluid composite

  Baseline and 12 weeks

• Change in the immune function (CD4+: CD8+ ratio)

  Baseline, 6 weeks and 12 weeks

• Change in cardiorespiratory fitness (Peak VO₂)

  Baseline and 12 weeks

• Change in Muscle Strength assessed using 1RM strength test

  Baseline and 12 weeks

• Change in Handgrip Strength Measured by Dynamometer

  Baseline, 6 weeks and 12 weeks

Other Outcomes (3)

• Study participation and retention rates

  12 weeks

• Adherence to supplement intervention

  12 weeks

• Adherence to exercise intervention

  12 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

The participants will be administered a powder oral nutritional supplement containing a synbiotic blend of prebiotics and probiotic, a protein blend and a micronutrient blend, combined with supervised exercise for a total of 12 weeks.

Behavioral: Supervised exercise program; Dietary Supplement: a balanced micronutrient blend

Interventions

Supervised exercise program BEHAVIORAL

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.

Intervention Arm

a balanced micronutrient blend DIETARY_SUPPLEMENT

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.

Intervention Arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• \. 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.

Sponsors & Collaborators

• National University of Singapore: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

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

Singapore, 117597, Singapore

RECRUITING

Study Officials

• Prof. Andrea Britta Maier, MD, PHD, FRACP

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mazzarine Dotou, PhD

CONTACT

+65 87264704; mazzarine@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oon Chiew Seng Professor in Medicine, Healthy Ageing and Dementia Research

Model Details: This is an open-label, single-arm, exploratory study in which 40 prefrail participants will receive a 12-week combined of an oral nutritional supplement in powder form containing a synbiotic blend of prebiotics and probiotic, a protein blend and a micronutrient blend and exercise intervention

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 6, 2026
• Study Start: September 22, 2025
• Primary Completion: April 30, 2026
• Study Completion: May 8, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting information will become available after study completion and publication of the main findings, with the end date to be determined.
• Access Criteria: Access to de-identified IPD will be provided upon reasonable request to qualified researchers with a methodologically sound proposal and appropriate ethical approval. Requests will be reviewed by the study investigators and data will be shared under a data use agreement specifying permitted uses, data security requirements, and restrictions on re-identification..

Locations

SG (1)