Synbiotic-enriched multi-nutrient supplement plus supervised exercise to improve longevity-related health markers 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.
This 12-week program will try a synbiotic-enriched multi-nutrient drink together with supervised exercise to see if it improves muscle strength and mass, gut microbiome, immune function, and thinking in pre-frail adults aged 50–80.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | National University of Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07454616 on ClinicalTrials.gov |
What this trial studies
This single-arm, open-label, single-centre study will enroll 40 prefrail men and women aged 50–80 in Singapore to receive a 12-week supervised exercise program alongside a synbiotic-enriched multi-nutrient oral supplement. Outcomes include measures of muscle mass and strength, gut microbiome composition, immune biomarkers, cognitive performance, and biological age markers measured before and after the intervention. Eligible participants must be Singapore residents with BMI ≥18 and meet Fried criteria for prefrailty, and they must avoid specified prebiotic/probiotic supplements and restrictive diets during the trial. The study will explore whether combining targeted nutrition with supervised exercise can produce measurable shifts across multiple ageing-related systems over a short intervention period.
Who should consider this trial
Good fit: Ideal candidates are Singapore residents aged 50–80 with BMI ≥18 who meet Fried criteria for prefrailty, can attend regular supervised sessions at the clinic, and are not taking excluded prebiotic/probiotic supplements or on restrictive diets.
Not a fit: Individuals who are already frail, have BMI over 30, are taking excluded supplements or special diets, have recent vaccinations or recent medications affecting gastrointestinal function, or cannot attend clinic visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could help preserve or restore muscle, immune, and cognitive function in pre-frail adults and potentially slow biological ageing to improve healthspan.
How similar studies have performed: Previous research shows that combining nutrition and exercise can improve muscle mass and function in older adults, but using a synbiotic-enriched supplement specifically to target gut microbiome, immune markers, and biological age is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Singapore
- MD11 Clinical Research Centre, #03-01, 10 Medical Drive — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Prof. Andrea Britta Maier, MD, PHD, FRACP — National University of Singapore
- Study coordinator: Mazzarine Dotou, PhD
- Email: mazzarine@nus.edu.sg
- Phone: +65 87264704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.