MItochondrial Intervention for Resilience in Older Adults With Coenzyme Q10
- Sponsor
- University Medical Centre Ljubljana
- Study ID
- NCT07772336
- Status
- Not Yet Recruiting
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Conditions
- Aging
- Frailty
- Mitochondria Health
- Mitochondrial Dysfunction
- Skin Aging
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Q10Vital® (CoQ10, ubiquinone) — DIETARY_SUPPLEMENTParticipants randomized to the intervention group will receive Q10Vital®, a CoQ10 formulation containing ubiquinone in a β-cyclodextrin complex designed to improve solubility and oral bioavailability. Participants will take 200 mg of CoQ10 once daily for 10 weeks. The intervention will be administered orally according to the study protocol. Q10Vital® has demonstrated improved bioavailability compared with standard crystalline ubiquinone and bioavailability comparable to ubiquinol in previous pharmacokinetic research. The intervention is intended to increase systemic CoQ10 availability and assess its potential effects on mitochondrial functional resilience and related biological and clinical measures of aging.
- Placebo — OTHERParticipants randomized to the control group will receive a matching placebo once daily for 10 weeks. The placebo will be identical or sufficiently similar in appearance, packaging, administration schedule, and dosage form to the Q10Vital® intervention to maintain blinding throughout the study. The placebo will contain no active CoQ10 ingredient. Participants will take the placebo orally according to the same schedule as the active intervention.
Study Details
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.
Key Dates
- First listed
- Aug 19, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2026
- Completion
- Feb 28, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CoQ10CoQ10 - 200 mg daily for 10 weeks
- Placebo Comparator: PlaceboMatching placebo for 10 weeks
Primary Outcome Measure
Change in plasma GDF-15 concentration [ Time Frame: Baseline to Week 10 ]
Central Contacts
- Mišo Šabović, MD, PhD+38615224280
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