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MItochondrial Intervention for Resilience in Older Adults With Coenzyme Q10

ConditionsFrailtyAgingMitochondria HealthSkin AgingMitochondrial Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity Medical Centre Ljubljana

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age 65 years or older.

Community-dwelling older adult.

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Q10Vital® (CoQ10, ubiquinone)

    Dietary supplement

    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.

  • Placebo

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: CoQ10Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in plasma GDF-15 concentration

Change in plasma GDF-15 concentration from baseline to the end of the 10-week intervention, comparing the CoQ10 and placebo groups.

Time frame
Baseline to Week 10

Secondary outcomes

1

CoQ10 availability

Change in plasma CoQ10 concentration

Time frame
Baseline to Week 10
2

Additional mitochondrial biomarkers

Change in plasma FGF-21 concentration

Time frame
Baseline to week 10

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Centre Ljubljana

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: