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Not Yet Recruiting NCT07772336

MItochondrial Intervention for Resilience in Older Adults With Coenzyme Q10

Conditions: Frailty, Aging, Mitochondria Health, Skin Aging, Mitochondrial Dysfunction

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 100
Sponsor: University Medical Centre Ljubljana

Summary

This randomized, double-blind, placebo-controlled clinical trial will investigate whether 10 weeks of CoQ10 supplementation can improve biological resilience and functional health in community-dwelling adults aged 65 years or older with signs of reduced biological resilience or prefrailty. Participants will be randomly assigned in a 1:1 ratio to receive either 200 mg of CoQ10 daily or matching placebo for 10 weeks. The study will assess the effects of CoQ10 supplementation on mitochondrial functional resilience, chronic low-grade inflammation, metabolic health, physical performance, cognitive function, and objective measures of skin aging. The study will also investigate whether baseline biological and functional characteristics can identify individuals who are more likely to benefit from CoQ10 supplementation. An exploratory aim is to develop a multidimensional composite index of biological resilience integrating molecular, biochemical, functional, and clinical measures of aging. The study will provide evidence on whether a mitochondria-targeted intervention with CoQ10 may represent a potential strategy for improving functional resilience and reducing features of prefrailty in older adults.

Eligibility Criteria

Inclusion Criteria * Age 65 years or older. * Community-dwelling older adult. * Presence of signs of reduced biological resilience or prefrailty, defined by meeting at least one of the following criteria: * Prefrailty according to the Fried frailty phenotype, defined as the presence of 1-2 of the following criteria: unintentional weight loss, self-reported exhaustion, reduced physical activity, slow walking speed, or reduced handgrip strength; or * Reduced physical performance, defined as a Short Physical Performance Battery (SPPB) score of ≤9; or * Increased functional vulnerability, defined as a Clinical Frailty Scale (CFS) score of ≥4. * Ability to understand the study procedures and comply with the study protocol. * Ability and willingness to provide written informed consent before participation. Exclusion Criteria * Established frailty with severe functional impairment that would interfere with study participation or outcome assessment. * Advanced dementia or cognitive impairment preventing informed consent or reliable participation in study assessments. * Active malignant disease or ongoing cancer treatment. * Acute inflammatory disease or acute infection at the time of enrollment. * Acute or unstable medical condition that could substantially affect functional performance, cognitive assessment, or the safety of the intervention. * Any medical condition considered by the investigator to make participation inappropriate or unsafe. * Current use of CoQ10 supplementation at a dose that could interfere with assessment of the study intervention, unless discontinued for the predefined washout period. * Known hypersensitivity or intolerance to CoQ10 or any component of the study product. * Participation in another interventional clinical trial that could affect the outcomes of the present study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07772336). StuddyBuddy aggregates publicly available trial information.