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Relatively Healthy VolunteersCEDIRANCT06666660

Daily Intake of Multivitamin & Mineral Supplementation Effects on Biological Age of Relatively Healthy Middle-aged Individuals

A study testing Multivitamin/Mineral supplements in people with Relatively Healthy Volunteers, run by National University of Singapore at 2 sites in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Micronutrients, such as vitamins and minerals, are required to sustain fundamental physiological processes in individuals. As individuals age, the risk of having suboptimal levels of micronutrients increases due to several age-related changes affecting their digestion and assimilation processes. Read more about this study

Who is it for?
Ages 40 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Relatively Healthy Volunteers
What is being tested?
Multivitamin/Mineral supplements
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
2 sitesSingapore
Study dates
23 Sep 2024to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 40 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants will be recruited if they fall in the following categories:
  • Relatively healthy middle aged (40-60 years) man or woman;
  • Completed the pre-screening requirements and has managed to schedule the screening visit;
  • Met the randomization criteria after the screening visit i.e., your biological age (as measured by blood DNA methylation) is greater than the chronological age;
  • Able to attend all 4 research visits for screening and research data collection at the NUHS Centre for Healthy Longevity (CHL) at Alexandra Hospital or MD11, National University of Singapore.
  • Willing to wear an OURA ring for 14 consecutive days after each study visits.
  • Willing to download study platform application into their mobile phone throughout the study period.

Who cannot join

  • Participants will NOT be recruited if they fall in any one or more of the following categories:
  • BMI lower than 18 kg/m2 or higher than or equal to 30 kg/m2 [25];
  • Pre-existing, or history of major cardiovascular diseases (coronary artery disease, heart failure, stroke, peripheral vascular disease, pulmonary hypertension), severe/uncontrolled hypertension (more than 1 prescribed medication), rheumatic heart disease, congenital heart disease, deep vein thrombosis, pulmonary embolism;
  • Type 1 diabetes and Type 2 diabetes;
  • Active cancer or treatment of cancer in the last 3 years;
  • Chronic obstructive pulmonary disease (COPD), severe asthma (taking daily medications);
Show all 19Show fewer
  • Pregnant women or women planning pregnancy in the next 12 months;
  • Multiple sclerosis or autoimmune/immune deficiency diseases such as Rheumatic arthritis, HIV, Crohn's disease;
  • Recent history of sepsis or infection (within 3 months of in-patient hospitalisation);
  • Any psychiatric disease or neurodegenerative diseases such as Alzheimer's Disease, Parkinson's Disease, Lewy body dementia, and any eating disorders;
  • Hepatitis and liver cirrhosis (independent of severity);
  • Severe kidney disease (GFR less than 30 ml/min/1.73 m2);
  • Skin disease (on systemic medication);
  • Individuals who are on another trial that requires them taking similar or partially similar investigational product (Appendix 1);
  • Individuals who are advised by their medical practitioner to take a MVM supplement;
  • Refuse to stop taking any non-prescribed supplements that contain the investigational product (Appendix 1) within one month before the screening visit and during the study period;
  • Taking a medically prescribed supplements that contains 2 or more of the ingredients of the investigational product (Appendix 1);
  • Individuals with planned hospitalization in the next 12 months;
  • Any serious medical illness which in the PI's judgment may jeopardise the participant by his or her participation in this study or may hamper his or her ability to perform and complete procedures required in the study.

Trial locations and contacts

2 sites in 1 country.

Andrea Britta Maier, MD PhD FRACP contact

6563793186

longevitytrials@nus.edu.sg

Muhammad Daniel Azlan Mahadzir, PhD contact

6563793187

longevitytrials@nus.edu.sg

Singapore2 sites, 2 recruiting
  • Healthy Longevity Translational Research Programme, Level 3, MD 11, 10 Medical Dr, Yong Loo Lin School of Medicine, National University of Singapore

    Singapore, Singapore, 117597

    Andrea Britta Maier, MD PhD FRACP, 6563793186/, longevitytrials@nus.edu.sg

    Muhammad Daniel Azlan Mahadzir, PhD, 6563793187, longevitytrials@nus.edu.sg

    Recruiting
  • Center for Healthy Longevity, Clinic L, Alexandra Hospital, 378 Alexandra Road

    Singapore, Singapore, 159964

    Andrea Britta Maier, MD PhD FRACP, 6563793186, lonegvitytrials@nus.edu.sg

    Muhammad Daniel Azlan Mahadzir, PhD, 6563793187, longevitytrials@nus.edu.sg

    Recruiting

Other trials in Singapore

About this study

Official title: Centrum; the Effect of Daily Intake of Multivitamin & Mineral Supplementation, on Biological Age in Relatively Healthy Middle-aged Individuals (CEDIRA)

Micronutrients, such as vitamins and minerals, are required to sustain fundamental physiological processes in individuals. As individuals age, the risk of having suboptimal levels of micronutrients increases due to several age-related changes affecting their digestion and assimilation processes. Suboptimal levels of micronutrients have been associated with increased risk of chronic diseases and accelerated ageing. Three years intake of a multivitamin and mineral supplement (MVM) improved global cognition, episodic memory and executive function in older adults. Furthermore, suboptimal micronutrient levels have been associated with a higher biological age, and diet and lifestyle interventions might lower the biological age measured by methylation clocks. Therefore, further evaluation is warranted to determine if MVM supplementation could improve the biological age and clinical outcomes in individuals with a higher biological age.

Read the detailed description

Accelerated ageing, characterized by a reduced function of multiple organ systems, can be measured by biological, clinical and digital biomarkers of aging. These biomarkers of aging are used to express the biological age of individuals. A higher biological age is not only associated with suboptimal micronutrients levels, but can also be reduced through lifestyle intervention, dietary intervention and nutrient supplementation. A frequently used biological biomarker of ageing is DNA methylation (DNAm) status, which is measured using a set of algorithm known as DNAm clock. This value has been accepted as a good indicator to capture fundamental molecular processes tied to the ageing process. Several studies using Vitamin D, Vitamin B12, and Vitamin C and E have shown positively modify DNAm clock, thus biological age. Henceforth, this study aims to determine if MVM supplementation can reduce the biological age in participants who are biologically older as assessed by DNAm clock.

Rationale for Study Population Middle aged individuals with a high biological age have a high risk of age-releated disesases. Efforts are being made to prevent the development and incidence of age-related diseases and therewith to reduce healthcare costs. Relatively healthy (no chronic disease), middle-aged (40-60 (inclusive) years old) individuals with a biological age higher than their chronological age will be included in this randomized, double-blinded, placebo-controlled trial.

Rationale for Study Design CEDIRA is a randomized, double-blinded, placebo-controlled trial including relatively healthy middle-aged individuals with a higher biological age to evaluate the effect of MVM supplementation for 12 months on biological age and other clinical and biological characteristics such as micronutrient levels in blood, anthropometrics, glucose control, lipid profile, cognition, muscle strength, skin health, lifestyle behaviour, and quality of life.

Being tested
Multivitamin/Mineral supplements, Placebo
Keywords
multivitamin, supplement, randomized controlled trial, biological age, DNA methylation, Epigenetic age

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multivitamin/Mineral supplementsDietary supplement

    Each participant will be given 180 MVM tablets in bottles at baseline visit, and another 180 tablets at 6-month visit. Participants will be advised to take 1 tablet orally daily, in the morning before food. Participants will be asked to return the remainder of dispensed MVM tablets, along with the bottle when they come for visit 2 and visit 3. This is done for investigational product accounting and checking for adherence to the assigned treatment arm.

  • PlaceboOther

    Each participant will be given 180 placebo tablets in bottles at baseline visit, and another 180 tablets at 6-month visit. Participants will be advised to take 1 tablet orally, daily, in the morning before food. Participants will be asked to return the remainder of dispensed placebo tablets, along with the bottle when they come for visit 2 and visit 3. This is done for investigational product accounting and checking for adherence to the assigned treatment arm. The placebo pills and bottles will be identical in appearance as MVM to ensure effective blinding.

Study groups in NCT06666660
Study groupRoleWhat they receive
Multivitamin/Mineral Supplement (MVM)ExperimentalParticipants in this arm will take 1.2g/day of MVM supplement from CENTRUM for 12 months.
Receives: Dietary Supplement: Multivitamin/Mineral supplements
PlaceboPlacebo comparatorParticipants in this arm will take 1.2g/day of placebo for 12 months.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in blood DNA methylation status, years

    DNA methylation aging clock

    Measured: Baseline, 6 months and 12 months

Secondary outcomes (28)
  1. Body Mass Index (BMI) change

    comparison of BMI at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  2. Waist-to-hip ratio change

    comparison of waist-to-hip ratio at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  3. Body fat mass (kg) change

    comparison of body fat mass at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  4. Skeletal muscle mass (kg) change

    comparison of skeletal muscle mass at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  5. Percentage body fat (%) change

    comparison of percentage body fat at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  6. Systolic blood pressure (mm Hg) change

    comparison of systolic blood pressure at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  7. Diastolic blood pressure (mm Hg) change

    comparison of diastolic blood pressure at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  8. Pulse rate (BPM) change

    comparison of pulse rate at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  9. Skin elasticity (mm/time) change

    comparison of skin elasticity measured by he resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) displayed as curves (penetration depth in mm/time) at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  10. Skin colour (L* a* b*) change

    comparison of skin colour measured using automatic calculation of ITA (Individual Typology Angle) that uses CIE L* a* b* values to classify 6 skin colours from very light to dark at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  11. Skin autofluorescence (au) change

    comparison of skin autofluorescence levels calculated by dividing the mean value of the emitted light intensity per nm between 420 and 600 nm by the mean value of the excitation light intensity per nm between 300 and 420 nm, expressed in arbitrary units (AU) at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  12. Complete blood count

    comparison of blood count at baseline, interim and end-of-trial

    Measured: Baseline, 6 months and 12 months

  13. Change in immune parameters: complete blood count

    comparison of immune parameters at baseline, interim and end-of-trial.

    Measured: Baseline, 6 months and 12 months

  14. Change in immune parameters: inflammatory parameters in serum (mg/dL)

    comparison of immune parameters at baseline, interim and end-of-trial

    Measured: Baseline, 6 months, 12 months

  15. Change in clinical blood parameters: renal function (mg/dL)

    comparison of clinical blood parameters at baseline, interim and end-of-trial

    Measured: Baseline, 6 months and 12 months

  16. Change in clinical blood parameters: lipid profile test (mmol/L)

    comparison of clinical blood parameters at baseline, interim and end-of-trial

    Measured: Baseline, 6 months and 12 months

  17. Change in clinical blood parameters: glucose (mg/dL)

    comparison of clinical blood parameters at baseline, 6 months and 12 months

    Measured: Baseline, 6 months and 12 months

  18. Change in clinical blood parameters: insulin (mg/dL)

    comparison of clinical blood parameters at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  19. Change in clinical blood parameters: glycelated haemoglobin, HbA1C (mmol/mol)

    comparison of clinical blood parameters at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  20. Change in clinical blood parameters: metabolites (mmol/l)

    comparison of clinical blood parameters at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  21. Change in micronutrient levels in blood

    comparison of micronutrient levels in blood at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  22. Change in micronutrient levels in urine

    comparison of micronutrient levels in urine at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  23. Change in cognition (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Test)

    comparison of cognition at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  24. Change in handgrip strength change (kg)

    comparison of handgrip strength at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  25. Change in quality of life (EuroQoL-5D-5L)

    comparison of quality of life at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  26. Change in sleep quality (modified Pittsburgh Sleep Quality Questionnaire)

    comparison of sleep quality at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  27. Change in sleep quality (Satisfaction, Alertness, Timing, Efficiency and Duration (SATED) Questionnaire)

    comparison of sleep quality at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

  28. Change in dietary intake (3-day Food Record)

    comparison of dietary intake at baseline, interim and end of trial

    Measured: Baseline, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2024
  2. Study start23 Sep 2024
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06666660
Sponsor's protocol ID
CEDIRA-NUS
Other IDs
HALEON
Acronym
CEDIRA
Status last verified
Oct 2024
First submitted
23 Oct 2024
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multivitamin/Mineral supplements in people with Relatively Healthy Volunteers, run by National University of Singapore at 2 sites 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 7 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Britta Maier, MD PhD FRACP (6563793186, longevitytrials@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 blood DNA methylation status, years (time frame: Baseline, 6 months and 12 months). 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 30 Oct 2024.

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