CoQ10 in Statin-associated Asthenia

Effect of Coenzyme Q10 on Physical Performance in Elderly Patients With Statin-associated Asthenia: a Double-blind, Randomized, Placebo-controlled Clinical Trial

This was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effects of supplementation with CoQ10 phytosome on physical performance in older adults with self-reported statin-associated asthenia.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Physical Performance
• Intervention / Treatment: Dietary supplement: Coenzyme Q10; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • University of Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• 65-80 years of age
• treatment for >6 months with statin monotherapy (i.e. enrolled individuals were asked to be on the same statin at the same dosage for >6 months)
• statin-associated asthenia for >3 months

Exclusion criteria:

• serious or disabling diseases (e.g. severe organ failure, malignancy or dementia)
• orthopedic disorders, myopathies and any other acute or chronic disease that could significantly affect the individual's perception of asthenia
• obesity (body mass index (BMI)> 30 Kg/m2)
• known gastrointestinal disorders potentially affecting the absorption of CoQ10

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coenzyme Q10; 2 pills of 150 mg CoQ10 phytosome (i.e. 300 mg CoQ10 phytosome per day)	Dietary supplement: Coenzyme Q10; 2 pills/day of 150 mg CoQ10 phytosome (i.e. 300 mg CoQ10 phytosome per day)
Placebo Comparator: Placebo; 2 pills of placebo per day	Other: Placebo; 2 pills/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on handgrip strength	We evaluated the effect on handgrip strength after 8 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo. A hand-held dynamometer was used to assess handgrip strength. Measurements were assessed according to the International standard protocols, and obtained after participants performed one familiarization trial with both hands.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on handgrip strength	We evaluated the effect on handgrip strength after 4 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo. A hand-held dynamometer was used to assess handgrip strength. Measurements were assessed according to the International standard protocols, and obtained after participants performed one familiarization trial with both hands.	4 weeks
Effect on statin-associated asthenia	We evaluated the effect on asthenia after 4 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo. Asthenia was assessed on a 10-point visual analogue scale (VAS), considering 0= absence of asthenia and 10= extreme asthenia.	4 weeks
Effect on statin-associated asthenia	We evaluated the effect on asthenia after 8 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo. Asthenia was assessed on a 10-point visual analogue scale (VAS), considering 0= absence of asthenia and 10= extreme asthenia.	8 weeks
Effect on 1-min sit-to-stand repetitions	We evaluated the effect on 1-min sit-to-stand repetitions after 4 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo.	4 weeks
Effect on 1-min sit-to-stand repetitions	We evaluated the effect on 1-min sit-to-stand repetitions after 8 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo.	8 weeks
Effect on 2-minute step test	We evaluated the effect on 2-minute step test after 4 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo.	4 weeks
Effect on 2-minute step test	We evaluated the effect on 2-minute step test after 8 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo.	8 weeks

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Principal Investigator: Claudio Borghi, MD, PhD, University of Bologna

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: April 21, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Statin; Coenzyme Q10; Asthenia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Asthenia; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: QELD_Stat_2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No