CoQ10 in Statin-associated Asthenia

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06391606
• Other study ID #: QELD_Stat_2017
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2024
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenia
• Hypercholesterolemia
• Physical Performance

Intervention

Dietary Supplement:
• Coenzyme Q10
2 pills/day of 150 mg CoQ10 phytosome (i.e. 300 mg CoQ10 phytosome per day)

Other:
• Placebo
2 pills/day

Locations

Country	Name	City	State
Italy	University of Bologna	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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