NCT07454616 Exploratory Study on a Multi-nutrient Supplement and Exercise Program for Improving Health Markers Associated to Longevity in Pre-frail Adults
| NCT ID | NCT07454616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University of Singapore |
| Condition | Pre-Frailty |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-09-22 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Prof. Andrea Britta Maier, MD, PHD, FRACP
PRINCIPAL INVESTIGATOR
National University of Singapore
Frequently Asked Questions
Who can join the NCT07454616 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Pre-Frailty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07454616 currently recruiting?
Yes, NCT07454616 is actively recruiting participants. Contact the research team at mazzarine@nus.edu.sg for enrollment information.
Where is the NCT07454616 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07454616 clinical trial?
NCT07454616 is sponsored by National University of Singapore. The principal investigator is Prof. Andrea Britta Maier, MD, PHD, FRACP at National University of Singapore. The trial plans to enroll 40 participants.