CoQ10 in Statin-associated Asthenia

Not Applicable

Completed

• Conditions: Physical Performance; Hypercholesterolemia
• Interventions: Other: Placebo; Dietary Supplement: Coenzyme Q10

• Registration Number: NCT06391606
• Lead Sponsor: University of Bologna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-21
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 pills of placebo per day
Coenzyme Q10	Coenzyme Q10	2 pills of 150 mg CoQ10 phytosome (i.e. 300 mg CoQ10 phytosome per day)

Primary Outcome Measures

Name	Time	Method
Effect on handgrip strength	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Effect on handgrip strength	4 weeks	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.
Effect on 2-minute step test	8 weeks	We evaluated the effect on 2-minute step test after 8 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo.
Effect on statin-associated asthenia	8 weeks	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.
Effect on 1-min sit-to-stand repetitions	8 weeks	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.

Trial Locations

Locations (1)

University of Bologna; 🇮🇹 Bologna, BO, Italy