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

NCT06666660 | Recruiting

• 2 other identifiers: CEDIRA-NUSHALEON
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Relatively Healthy Volunteers

Keywords

multivitamin; supplement; randomized controlled trial; biological age; DNA methylation; Epigenetic age

Outcome Measures

Primary Outcomes (1)

• Change in blood DNA methylation status, years

  DNA methylation aging clock

  Baseline, 6 months and 12 months

Secondary Outcomes (28)

• Body Mass Index (BMI) change

  Baseline, 6 months and 12 months

• Waist-to-hip ratio change

  Baseline, 6 months and 12 months

• Body fat mass (kg) change

  Baseline, 6 months and 12 months

• Skeletal muscle mass (kg) change

  Baseline, 6 months and 12 months

• Percentage body fat (%) change

  Baseline, 6 months and 12 months

Study Arms (2)

Multivitamin/Mineral Supplement (MVM)

EXPERIMENTAL

Participants in this arm will take 1.2g/day of MVM supplement from CENTRUM for 12 months.

Dietary Supplement: Multivitamin/Mineral supplements

Placebo

PLACEBO COMPARATOR

Participants in this arm will take 1.2g/day of placebo for 12 months.

Other: Placebo

Interventions

Multivitamin/Mineral supplements DIETARY_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.

Multivitamin/Mineral Supplement (MVM)

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• National University of Singapore: lead
• HALEON: collaborator

Study Sites (2)

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, Singapore

RECRUITING

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

Singapore, Singapore, 159964, Singapore

RECRUITING

MeSH Terms

Interventions

Geritol

Study Officials

• Andrea Britta Maier, MD PhD FRACP

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Britta Maier, MD PhD FRACP

CONTACT

6563793186; longevitytrials@nus.edu.sg

Muhammad Daniel Azlan Mahadzir, PhD

CONTACT

6563793187; longevitytrials@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 30, 2024
• Study Start: September 23, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)