MItochondrial Intervention for Resilience in Older Adults With Coenzyme Q10

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.

Conditions

• Frailty
• Aging
• Mitochondria Health
• Skin Aging
• Mitochondrial Dysfunction

Interventions

DIETARY_SUPPLEMENT

Q10Vital® (CoQ10, ubiquinone)

Participants 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.

OTHER

Placebo

Participants 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana

  lead OTHER

Principal Investigators

• Mišo Šabović, MD, PhD · Department of Vascular Diseases, Division of Internal Medicine, University Medical Centre Ljubljana

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2026-12-31

Completion

2027-02-28