Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT06666660
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.
Study:
NCT06666660
Study Brief:
Protocol Section:
NCT06666660