An interventional study of Multivitamin/Mineral supplements and Placebo in Relatively Healthy Volunteers, sponsored by National University of Singapore. Recruiting at 2 sites in Singapore. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by National University of Singapore · Not applicable, Interventional, and Health services research
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.
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.
National University of Singapore is the lead sponsor of 206 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited if they fall in the following categories:
Exclusion Criteria
Participants will NOT be recruited if they fall in any one or more of the following categories:
Participants in this arm will take 1.2g/day of MVM supplement from CENTRUM for 12 months.
Dietary Supplement: Multivitamin/Mineral supplements
Participants in this arm will take 1.2g/day of placebo for 12 months.
Other: Placebo
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.
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.
Change in blood DNA methylation status, years
DNA methylation aging clock
Time frame: Baseline, 6 months and 12 months
Body Mass Index (BMI) change
comparison of BMI at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Waist-to-hip ratio change
comparison of waist-to-hip ratio at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Body fat mass (kg) change
comparison of body fat mass at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Skeletal muscle mass (kg) change
comparison of skeletal muscle mass at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Percentage body fat (%) change
comparison of percentage body fat at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Systolic blood pressure (mm Hg) change
comparison of systolic blood pressure at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Diastolic blood pressure (mm Hg) change
comparison of diastolic blood pressure at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Pulse rate (BPM) change
comparison of pulse rate at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
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
Time frame: Baseline, 6 months and 12 months
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
Time frame: Baseline, 6 months and 12 months
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
Time frame: Baseline, 6 months and 12 months
Complete blood count
comparison of blood count at baseline, interim and end-of-trial
Time frame: Baseline, 6 months and 12 months
Change in immune parameters: complete blood count
comparison of immune parameters at baseline, interim and end-of-trial.
Time frame: Baseline, 6 months and 12 months
Change in immune parameters: inflammatory parameters in serum (mg/dL)
comparison of immune parameters at baseline, interim and end-of-trial
Time frame: Baseline, 6 months, 12 months
Change in clinical blood parameters: renal function (mg/dL)
comparison of clinical blood parameters at baseline, interim and end-of-trial
Time frame: Baseline, 6 months and 12 months
Change in clinical blood parameters: lipid profile test (mmol/L)
comparison of clinical blood parameters at baseline, interim and end-of-trial
Time frame: Baseline, 6 months and 12 months
Change in clinical blood parameters: glucose (mg/dL)
comparison of clinical blood parameters at baseline, 6 months and 12 months
Time frame: Baseline, 6 months and 12 months
Change in clinical blood parameters: insulin (mg/dL)
comparison of clinical blood parameters at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Change in clinical blood parameters: glycelated haemoglobin, HbA1C (mmol/mol)
comparison of clinical blood parameters at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Change in clinical blood parameters: metabolites (mmol/l)
comparison of clinical blood parameters at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Change in micronutrient levels in blood
comparison of micronutrient levels in blood at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Change in micronutrient levels in urine
comparison of micronutrient levels in urine at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Change in cognition (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Test)
comparison of cognition at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Change in handgrip strength change (kg)
comparison of handgrip strength at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Change in quality of life (EuroQoL-5D-5L)
comparison of quality of life at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Change in sleep quality (modified Pittsburgh Sleep Quality Questionnaire)
comparison of sleep quality at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Change in sleep quality (Satisfaction, Alertness, Timing, Efficiency and Duration (SATED) Questionnaire)
comparison of sleep quality at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Change in dietary intake (3-day Food Record)
comparison of dietary intake at baseline, interim and end of trial
Time frame: Baseline, 6 months and 12 months
Plan to share: No
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National University of Singapore