NCT06666660

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: National University of Singapore · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Relatively Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Multivitamin/Mineral supplements	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.
OTHER	Placebo	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.

Timeline

• Start date: 2024-09-23
• Primary completion: 2025-04-30
• Completion: 2025-06-30
• First posted: 2024-10-30
• Last updated: 2024-10-30

Locations

2 sites across 1 country: Singapore