Pre-FrailtyRtMNCT07454616
Exploratory Study on a Multi-nutrient Supplement and Exercise Program for Improving Health Markers Associated to Longevity in Pre-frail Adults
A study testing Supervised exercise program and a balanced micronutrient blend in people with Pre-Frailty and Aging, run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Pre-Frailty, Aging
- What is being tested?
- Supervised exercise program and a balanced micronutrient blend
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Sep 2025to 8 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
MD11 Clinical Research Centre, #03-01, 10 Medical Drive
Singapore, 117597
Mazzarine Dotou, PhD, MBA, +65 87264704, mazzarine@nus.edu.sg
Andrea Britta Maier, MD, PhD, FRACP
About this study
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.
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.
Read the detailed description
As we age, biological age, gut microbiome, muscle, immune, and cognition undergo gradual decline. Aging is associated with progressive declines in multiple physiological systems which affects healthspan (years free from diseases). Skeletal muscle undergoes atrophy and functional impairment, characterized by reductions in muscle fiber size and number. Cognitive decline occurs with age and is associated with structural and functional brain changes, contributing to impairments in memory, attention, and executive function. The aging immune system exhibits immuno-senescence, marked by diminished adaptive immune responses, altered T-cell function, and chronic low-grade inflammation. To reduce the healthspan-lifespan gap, Healthy Longevity Medicine (HLM) aims to optimise health and healthspan by targeting the ageing processes across the lifespan. To help mitigate these age-related changes, research is increasingly focused on developing targeted interventions such as nutritional supplements and structured exercise programs. Objective: To explore the effects of a 12-week intervention including supervised exercise and a Synbiotic enriched oral nutritional supplement on gut (microbiome), muscle, immune, cognition and biological age outcomes in pre-frail individuals aged 50-80 years. Study design: This is a single-arm, open-label, interventional, exploratory, single-centre study in which 40 pre-frail male and female individuals aged 50-80 years will be administered a novel multi-nutrient supplement containing synbiotics combined with supervised exercise for a total of 12 weeks.
- Conditions
- Pre-Frailty, Aging
- Being tested
- Supervised exercise program, a balanced micronutrient blend
- Keywords
- Prefrail elderly, Gut microbiome, Nutritional supplementation, supervised exercise, Biological age markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise programBehavioural
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.
a balanced micronutrient blendDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Supervised exercise program; Dietary Supplement: a balanced micronutrient blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, 6 weeks and 12 weeks
Secondary outcomes (21)
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]
Measured: Baseline and 12 weeks
Change in the immune function (CD4+: CD8+ ratio)
Change from baseline at 6 weeks and 12 weeks in CD4+: CD8+ in T-cell ratio
Measured: Baseline, 6 weeks and 12 weeks
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)
Measured: Baseline and 12 weeks
Change in Muscle Strength assessed using 1RM strength test
Change from baseline to 12 weeks in 1RM strength (Smith machine bench press) (Kg)
Measured: Baseline and 12 weeks
Change in Handgrip Strength Measured by Dynamometer
Change from baseline to Week 6 and Week 12 in handgrip strength measured using a calibrated handgrip dynamometer. Grip strength was recorded in kilograms (kg) according to standardized testing procedures.
Measured: Baseline, 6 weeks and 12 weeks
Stool consistency, frequency and gastrointestinal tolerance
Stool consistency and frequency will be measured during the study. Gastrointestinal tolerance will be evaluated through participant-reported symptoms.
Measured: baseline, 12 weeks
Change in Biological age determined by DNAm clocks
Change from baseline to 12 weeks in biological age derived from DNA methylation profiling
Measured: baseline, 12 weeks
Change in advanced glycation end-products (AGEs) assessed using skin autofluorescence.
Change from baseline to 12 weeks in circulating and/or tissue levels of advanced glycation end-products (AGEs), assessed using skin autofluorescence (AU).
Measured: Baseline, 12 weeks
Change in inflammatory markers (IL-6, IL-10, TNF-α and IFN-γ)
Change from baseline to Week 6 and Week 12 in serum inflammatory markers including interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ). Concentrations were measured in picograms per milliliter (pg/mL) using validated laboratory assay methods.
Measured: Baseline, 6 weeks and 12 weeks
Change in immune function as measured by Lymphocyte/neutrophil ratio
Change from baseline to 6 weeks and 12 weeks in Lymphocyte/neutrophil cells ratio
Measured: Baseline, 6 weeks and 12 weeks
Change in blood pressure measured using SphygmoCor-XCEL
Change from baseline to Week 6 and Week 12 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured in millimeters of mercury (mmHg) using the AtCor Medical SphygmoCor XCEL device.
Measured: baseline, 6 weeks, 12 weeks
Change in Arterial stiffness measured via SphygmoCor-XCEL
Change from baseline to Week 12 in arterial stiffness assessed using the AtCor Medical SphygmoCor XCEL device. Arterial stiffness was evaluated by carotid-femoral pulse wave velocity (cfPWV), reported in meters per second (m/s).
Measured: Baseline and 12 weeks
Change in Physical Activity Levels Measured by Wearable Devices
Change from baseline to Week 12 in physical activity levels (daily steps) assessed using wearable devices (e.g., OURA ring).
Measured: baseline, 12 weeks
Change in heart rate measured with SphygmoCor-XCEL
Change from baseline at 6 weeks and 12 weeks in heart rate (pbm)
Measured: Baseline, 6 weeks and 12 weeks
Change in Lean Mass measured by Dual-Energy X-ray Absorptiometry (DXA)
Change from baseline in Lean Mass measured by Dual-Energy X-ray Absorptiometry (DXA)
Measured: Baseline and 12 weeks
Change in Body Composition Measured by Bioimpedance (InBody 770)
Change in Body Composition (fat mass and fat-free mass, Kg) measured by Bioimpedance (InBody 770)
Measured: Baseline and 12 weeks
Change in Quality of life assessed by The 36-Item Short Form Health Survey questionnaire (SF-36)
Change from baseline to 12 weeks in tThe 36-Item Short Form Health Survey questionnaire (SF-36) [Score ranging from 0 to 100]
Measured: baseline, 12 weeks
Change in Quality of Life Measured by EuroQol 5-Dimensions (EQ-5D)
Change from baseline to Week 12 in health-related quality of life as measured by the EuroQol 5-Dimensions (EQ-5D) questionnaire. The EQ-5D assesses five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted to a single EQ-5D index value using a country-specific value set.
The EQ-5D index score typically ranges from less than 0 (health states worse than death) to 1.0 (full health).
Measured: Baseline, 12 weeks
Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)
Change from baseline to Week 12 in sleep quality assessed using the validated Pittsburgh Sleep Quality Index (PSQI) questionnaire. Scores range from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline and 12 weeks
Change in Sleep Quality Measured by SATED Sleep Questionnaire
Change from baseline to Week 12 in sleep quality assessed using the SATED questionnaire. Scores range from 0 to 24, with higher scores indicating better sleep quality.
Measured: Baseline, 12 weeks
Change in Sleep Efficiency Measured by Wearable Device
Change from baseline to Week 12 in sleep efficiency assessed using a wearable device (e.g., OURA ring). Sleep efficiency is reported as a percentage (%), with higher values indicating better sleep quality.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start22 Sep 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion8 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Principal investigator, Andrea Maier, National University of Singapore
- Investigators
- Prof. Andrea Britta Maier, MD, PHD, FRACP, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454616
- Sponsor's protocol ID
- NUS-IRB-2025-418
- Acronym
- RtM
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary, secondary and other outcome measures reported in this study, will be made available on request. Data will be fully de-identified and will not include direct identifiers. Raw data (e.g., DNA methylation, microbiome sequencing) may be shared in processed or aggregated form, as appropriate, to minimize re-identification risk.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07454616
- Acronym / sponsor ID
- RtM / NUS-IRB-2025-418
- Conditions
- Pre-Frailty, Aging
- Keywords
- Prefrail elderly, Gut microbiome, Nutritional supplementation, supervised exercise, Biological age markers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 8 May 2026 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As we age, biological age, gut microbiome, muscle, immune, and cognition undergo gradual decline. Aging is associated with progressive declines in multiple physiological systems which affects healthspan (years free from diseases). Skeletal muscle undergoes atrophy and functional impairment, characterized by reductions in muscle fiber size and number. Cognitive decline occurs with age and is associated with structural and functional brain changes, contributing to impairments in memory, attention, and executive function. The aging immune system exhibits immuno-senescence, marked by diminished adaptive immune responses, altered T-cell function, and chronic low-grade inflammation. To reduce the healthspan-lifespan gap, Healthy Longevity Medicine (HLM) aims to optimise health and healthspan by targeting the ageing processes across the lifespan. To help mitigate these age-related changes, research is increasingly focused on developing targeted interventions such as nutritional supplements and structured exercise programs. Objective: To explore the effects of a 12-week intervention including supervised exercise and a Synbiotic enriched oral nutritional supplement on gut (microbiome), muscle, immune, cognition and biological age outcomes in pre-frail individuals aged 50-80 years. Study design: This is a single-arm, open-label, interventional, exploratory, single-centre study in which 40 pre-frail male and female individuals aged 50-80 years will be administered a novel multi-nutrient supplement containing synbiotics combined with supervised exercise for a total of 12 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Supervised exercise program, Dietary Supplement: a balanced micronutrient blendThe 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exercise programA 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. | Behavioural | Intervention Arm |
| a balanced micronutrient blendA 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. | Dietary supplement | Intervention Arm |
Primary outcome
Change in muscle mass measured via B- mode ultrasound
Time frame: Baseline and 12 weeks
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
Time frame: Baseline, 6 weeks and 12 weeks
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.
21 secondary outcomes
Change in cognitive performance National Institutes of Health Toolbox Cognition Battery - Fluid composite
Time frame: Baseline and 12 weeks
Change in the immune function (CD4+: CD8+ ratio)
Time frame: Baseline, 6 weeks and 12 weeks
Change in cardiorespiratory fitness (Peak VO₂)
Time frame: Baseline and 12 weeks
Change in Muscle Strength assessed using 1RM strength test
Time frame: Baseline and 12 weeks
Change in Handgrip Strength Measured by Dynamometer
Time frame: Baseline, 6 weeks and 12 weeks
Stool consistency, frequency and gastrointestinal tolerance
Time frame: baseline, 12 weeks
Change in Biological age determined by DNAm clocks
Time frame: baseline, 12 weeks
Change in advanced glycation end-products (AGEs) assessed using skin autofluorescence.
Time frame: Baseline, 12 weeks
Change in inflammatory markers (IL-6, IL-10, TNF-α and IFN-γ)
Time frame: Baseline, 6 weeks and 12 weeks
Change in immune function as measured by Lymphocyte/neutrophil ratio
Time frame: Baseline, 6 weeks and 12 weeks
Change in blood pressure measured using SphygmoCor-XCEL
Time frame: baseline, 6 weeks, 12 weeks
Change in Arterial stiffness measured via SphygmoCor-XCEL
Time frame: Baseline and 12 weeks
Change in Physical Activity Levels Measured by Wearable Devices
Time frame: baseline, 12 weeks
Change in heart rate measured with SphygmoCor-XCEL
Time frame: Baseline, 6 weeks and 12 weeks
Change in Lean Mass measured by Dual-Energy X-ray Absorptiometry (DXA)
Time frame: Baseline and 12 weeks
Change in Body Composition Measured by Bioimpedance (InBody 770)
Time frame: Baseline and 12 weeks
Change in Quality of life assessed by The 36-Item Short Form Health Survey questionnaire (SF-36)
Time frame: baseline, 12 weeks
Change in Quality of Life Measured by EuroQol 5-Dimensions (EQ-5D)
Time frame: Baseline, 12 weeks
Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 12 weeks
Change in Sleep Quality Measured by SATED Sleep Questionnaire
Time frame: Baseline, 12 weeks
Change in Sleep Efficiency Measured by Wearable Device
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary, secondary and other outcome measures reported in this study, will be made available on request. Data will be fully de-identified and will not include direct identifiers. Raw data (e.g., DNA methylation, microbiome sequencing) may be shared in processed or aggregated form, as appropriate, to minimize re-identification risk.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Andrea Britta Maier, MD, PHD, FRACP principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise program and a balanced micronutrient blend in people with Pre-Frailty and Aging, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mazzarine Dotou, PhD (+65 87264704, mazzarine@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle mass measured via B- mode ultrasound (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.