Bioavailability and Impact of Coenzyme Q10 in Stressing Exercise in Senescence Athletes

NCT03893864 | Completed Phase 1 DMC

• 1 other identifier: CAR-2018 CoQ10
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

It is proposed to establish a group of subjects composed of 10 healthy individuals of\> 50 years and \<65, physically active, without metabolic or inflammatory pathology. All of them will undergo a health examination and the physical condition and the absence of contraindication of the sports practice will be characterized through a monitored effort test. Each subject will take a capsule of coenzyme Q10® INDENA for 30 days. The dose to be administered is 100 mg/d of CoQ10 a with food (noon). The state of physical condition and the biochemical and biological variables that reflect oxidative stress and mitochondrial functioning before and after the intervention will be measured.

Conditions

Coenzyme Q10; Oxidative Stress; Aging

Keywords

Coenzyme Q10; Ubiquinone; Ubiquinol; Oxidative pattern; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in the concentration of CoQ10 on different tissues after supplementation for a month

  Evaluate the change in the concentration of CoQ10 on plasma, muscle, monouclear cells and urinary epithelium, by specific analysis of every sample tissue at the Pathology Dept and the Methabolopathies Dept of the Pediatric Hospital of Sant Joan de Deu

  6 months

Secondary Outcomes (2)

• Effect of the CoQ10 supplementation on the oxidative response to stressing exercise under heat and humidity

  3 months

• Effect of the CoQ10 supplementation on the inflammatory response to stressing exercise under heat and humidity

  3 months

Study Arms (2)

Intervention Group (CoQ10)

EXPERIMENTAL

Runner athletes \> 50 years old, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions

Dietary Supplement: Administration of a product with Fitosomed Ubiquinone; Procedure: Coenzyme Q10 level in muscle biopsies; Diagnostic Test: Coenzyme Q10 level in plasma, blood cells, urine cells; Diagnostic Test: Total antioxidant capacity after strenous exercise

Control Group

ACTIVE COMPARATOR

Runner athletes \> 50 years old with the same characteristics as the Experimental arm, served as control group, maintaining the training sessions Both groups were evaluated before and after the month of intervention or no intervention.

Diagnostic Test: Coenzyme Q10 level in plasma, blood cells, urine cells; Diagnostic Test: Total antioxidant capacity after strenous exercise

Interventions

Administration of a product with Fitosomed Ubiquinone DIETARY_SUPPLEMENT

Healthy runner athletes, \> 50 years old, without any chronic illness, without any other nutritional supplementation or drug intervention, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions.

Also known as: Coenzyme Q10, UbiQuisome

Intervention Group (CoQ10)

Coenzyme Q10 level in muscle biopsies PROCEDURE

Determination of the muscle Ubiquinone concentration, the metabolic and structure characteristics of the muscle before and after one month of supplementation

Also known as: Muscle Biopsy

Intervention Group (CoQ10)

Coenzyme Q10 level in plasma, blood cells, urine cells DIAGNOSTIC_TEST

Determination of Ubiquinone concentration in different tissues before and after one month of supplementation or not

Control Group; Intervention Group (CoQ10)

Total antioxidant capacity after strenous exercise DIAGNOSTIC_TEST

Determination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber

Also known as: TAC after exercise

Control Group; Intervention Group (CoQ10)

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Athletes over 50 active at this time
• Runners
• Without medical treatment
• Without acute or chronic inflmatory disease
• No recent infectious processes
• No muscle or joint injuries in the last 6 months
• Stable training during the evaluation period
• Without taking supplementation

You may not qualify if:

• Injuried, sickness, during the study
• Lack of compromise
• Inflamatory process
• Abandon the training by any reason

Sponsors & Collaborators

• Centre d'Alt Rendiment: lead
• Hospital Sant Joan de Deu: collaborator
• University of Barcelona: collaborator
• Indena S.p.A: collaborator

Study Sites (1)

Centre D'Alt Rendiment, Sant Cugat

Sant Cugat Del Vallés, Barcelona, 08174, Spain

Location

MeSH Terms

Conditions

Motor Activity

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Rafael Artuch, MD, PhD

  Hospital Sant Joan de Deu, Barcelona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants of the interventional group know they are taking a nutritional supplementation in study to improve health condition. Only the outcome evaluators, blood analisis, exercise testing data processing, muscle biopy analisys do not know if the samples come from control or interventional group
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional study of 22 subjects, 12 under supplemental intervention and 10 as control subjects. Both groups are similar subjects with same characteristics and condition. The interventional group will receive a supplementaction of CoQ10 (100 mg) during one month, the Control group nothing.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 28, 2019
• Study Start: March 1, 2018
• Primary Completion: May 30, 2018
• Study Completion: February 28, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)