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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 21, 2024
CompletedFirst Posted
Study publicly available on registry
April 30, 2024
CompletedApril 30, 2024
April 1, 2024
5 months
April 21, 2024
April 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Effect on handgrip strength
4 weeks
Effect on statin-associated asthenia
4 weeks
Effect on statin-associated asthenia
8 weeks
Effect on 1-min sit-to-stand repetitions
4 weeks
Effect on 1-min sit-to-stand repetitions
8 weeks
- +2 more secondary outcomes
Study Arms (2)
Coenzyme Q10
ACTIVE COMPARATOR2 pills of 150 mg CoQ10 phytosome (i.e. 300 mg CoQ10 phytosome per day)
Placebo
PLACEBO COMPARATOR2 pills of placebo per day
Interventions
2 pills/day of 150 mg CoQ10 phytosome (i.e. 300 mg CoQ10 phytosome per day)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Bologna
Bologna, BO, 40138, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio Borghi, MD, PhD
University of Bologna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
April 21, 2024
First Posted
April 30, 2024
Study Start
October 1, 2018
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
April 30, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share