Daily Intake of Multivitamin & Mineral Supplementation Effects on Biological Age of Relatively Healthy Middle-aged Individuals
- Conditions
- Relatively Healthy Volunteers
- Registration Number
- NCT06666660
- Lead Sponsor
- National University of Singapore
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in blood DNA methylation status, years Baseline, 6 months and 12 months DNA methylation aging clock
- Secondary Outcome Measures
Name Time Method Body Mass Index (BMI) change Baseline, 6 months and 12 months comparison of BMI at baseline, interim and end of trial
Waist-to-hip ratio change Baseline, 6 months and 12 months comparison of waist-to-hip ratio at baseline, interim and end of trial
Body fat mass (kg) change Baseline, 6 months and 12 months comparison of body fat mass at baseline, interim and end of trial
Skeletal muscle mass (kg) change Baseline, 6 months and 12 months comparison of skeletal muscle mass at baseline, interim and end of trial
Percentage body fat (%) change Baseline, 6 months and 12 months comparison of percentage body fat at baseline, interim and end of trial
Systolic blood pressure (mm Hg) change Baseline, 6 months and 12 months comparison of systolic blood pressure at baseline, interim and end of trial
Diastolic blood pressure (mm Hg) change Baseline, 6 months and 12 months comparison of diastolic blood pressure at baseline, interim and end of trial
Pulse rate (BPM) change Baseline, 6 months and 12 months comparison of pulse rate at baseline, interim and end of trial
Skin elasticity (mm/time) change Baseline, 6 months and 12 months 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
Skin colour (L* a* b*) change Baseline, 6 months and 12 months 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
Skin autofluorescence (au) change Baseline, 6 months and 12 months 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
Complete blood count Baseline, 6 months and 12 months comparison of blood count at baseline, interim and end-of-trial
Change in immune parameters: complete blood count Baseline, 6 months and 12 months comparison of immune parameters at baseline, interim and end-of-trial.
Change in immune parameters: inflammatory parameters in serum (mg/dL) Baseline, 6 months, 12 months comparison of immune parameters at baseline, interim and end-of-trial
Change in clinical blood parameters: renal function (mg/dL) Baseline, 6 months and 12 months comparison of clinical blood parameters at baseline, interim and end-of-trial
Change in clinical blood parameters: glucose (mg/dL) Baseline, 6 months and 12 months comparison of clinical blood parameters at baseline, 6 months and 12 months
Change in clinical blood parameters: insulin (mg/dL) Baseline, 6 months and 12 months comparison of clinical blood parameters at baseline, interim and end of trial
Change in clinical blood parameters: lipid profile test (mmol/L) Baseline, 6 months and 12 months comparison of clinical blood parameters at baseline, interim and end-of-trial
Change in clinical blood parameters: glycelated haemoglobin, HbA1C (mmol/mol) Baseline, 6 months and 12 months comparison of clinical blood parameters at baseline, interim and end of trial
Change in micronutrient levels in blood Baseline, 6 months and 12 months comparison of micronutrient levels in blood at baseline, interim and end of trial
Change in micronutrient levels in urine Baseline, 6 months and 12 months comparison of micronutrient levels in urine at baseline, interim and end of trial
Change in cognition (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Test) Baseline, 6 months and 12 months comparison of cognition at baseline, interim and end of trial
Change in handgrip strength change (kg) Baseline, 6 months and 12 months comparison of handgrip strength at baseline, interim and end of trial
Change in clinical blood parameters: metabolites (mmol/l) Baseline, 6 months and 12 months comparison of clinical blood parameters at baseline, interim and end of trial
Change in quality of life (EuroQoL-5D-5L) Baseline, 6 months and 12 months comparison of quality of life at baseline, interim and end of trial
Change in sleep quality (modified Pittsburgh Sleep Quality Questionnaire) Baseline, 6 months and 12 months comparison of sleep quality at baseline, interim and end of trial
Change in sleep quality (Satisfaction, Alertness, Timing, Efficiency and Duration (SATED) Questionnaire) Baseline, 6 months and 12 months comparison of sleep quality at baseline, interim and end of trial
Change in dietary intake (3-day Food Record) Baseline, 6 months and 12 months comparison of dietary intake at baseline, interim and end of trial
Trial Locations
- Locations (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
Center for Healthy Longevity, Clinic L, Alexandra Hospital, 378 Alexandra Road
🇸🇬Singapore, Singapore