MItochondrial Intervention for Resilience in Older Adults With Coenzyme Q10

NCT07772336 | Not Yet Recruiting

• 1 other identifier: UKCL-Q10
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

frailty; aging; older adults; Coenzyme Q10; mitochondrial dysfunction; geroscience; functional aging

Outcome Measures

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.

  Baseline to Week 10

Secondary Outcomes (2)

• CoQ10 availability

  Baseline to Week 10

• Additional mitochondrial biomarkers

  Baseline to week 10

Study Arms (2)

CoQ10

EXPERIMENTAL

CoQ10 - 200 mg daily for 10 weeks

Dietary Supplement: Q10Vital® (CoQ10, ubiquinone)

Placebo

PLACEBO COMPARATOR

Matching placebo for 10 weeks

Other: Placebo

Interventions

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.

CoQ10

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

MeSH Terms

Conditions

Frailty; Mitochondrial Diseases

Interventions

coenzyme Q10; Ubiquinone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Study Officials

• Mišo Šabović, MD, PhD

  Department of Vascular Diseases, Division of Internal Medicine, University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mišo Šabović, MD, PhD

CONTACT

+38615224280; miso.sabovic@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be quadruple-masked. Participants, care providers, investigators, and outcome assessors will be unaware of treatment allocation. CoQ10 and placebo will be provided in identical packaging and dosage forms to maintain blinding throughout the 10-week intervention. Treatment allocation will remain concealed until completion of the predefined study analyses, except when unblinding is required for participant safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Mišo Šabović, MD, PhD

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The intervention group will receive 200 mg of CoQ10 daily for 10 weeks, while the control group will receive matching placebo. Participants, investigators, and outcome assessors will be blinded to treatment allocation. Assessments of biological, functional, cognitive, metabolic, and skin-related outcomes will be performed at baseline and after the 10-week intervention. Changes in outcomes will be compared between the CoQ10 and placebo groups.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share