Hypercholesterolemia, Physical Performance
Conditions
Keywords
Statin, Asthenia, Coenzyme Q10
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.
Interventions
DIETARY_SUPPLEMENTCoenzyme Q10
2 pills/day of 150 mg CoQ10 phytosome (i.e. 300 mg CoQ10 phytosome per day)
OTHERPlacebo
2 pills/day
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 statin-associated asthenia | 4 weeks | 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. |
| Effect on 1-min sit-to-stand repetitions | 4 weeks | 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. |
| Effect on 2-minute step test | 4 weeks | We evaluated the effect on 2-minute step test after 4 weeks of dietary supplementation with CoQ10 phytosome compared to either baseline and placebo. |
Countries
Italy
Outcome results
None listed