ClinicalTrials.gg
CompletedNCT06391606Updated Apr 30, 2024

CoQ10 in Statin-associated Asthenia

An interventional study of Coenzyme Q10 and Placebo in Hypercholesterolemia and Physical Performance, sponsored by University of Bologna. Completed at 1 site in Italy. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by University of Bologna · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 6 months after the study started (first participant enrolled Oct 2018, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypercholesterolemia
  • Physical Performance

Keywords

  • Statin
  • Asthenia
  • Coenzyme Q10
03

In context

Hypercholesterolemia

1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.

This study's enrollment of 60 is below the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • serious or disabling diseases (e.g. severe organ failure, or dementia)
  • orthopedic disorders, myopathies and any other acute or chronic disease that could significantly affect the individual's perception of asthenia
  • obesity ( (BMI)> 30 Kg/m2)
  • known gastrointestinal disorders potentially affecting the absorption of CoQ10
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Coenzyme Q10

    2 pills of 150 mg CoQ10 phytosome (i.e. 300 mg CoQ10 phytosome per day)

    Dietary Supplement: Coenzyme Q10

  • Placebo comparator
    Placebo

    2 pills of placebo per day

    Other: Placebo

Interventions

  • Dietary supplementCoenzyme Q10

    2 pills/day of 150 mg CoQ10 phytosome (i.e. 300 mg CoQ10 phytosome per day)

  • OtherPlacebo

    2 pills/day

06

What researchers measure

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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.

    Time frame: 4 weeks

  3. 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.

    Time frame: 8 weeks

  4. 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.

    Time frame: 4 weeks

  5. 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.

    Time frame: 8 weeks

  6. 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.

    Time frame: 4 weeks

  7. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • University of Bologna
    Bologna, BO 40138, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06391606
Responsible party
Claudio Borghi (Prof. Dr., University of Bologna) — Principal investigator
First posted
Apr 30, 2024
Start date
Oct 1, 2018
Primary completion
Mar 1, 2019
Completion
Mar 1, 2019
Last update
Apr 30, 2024

Study contacts

Claudio Borghi, MD, PhD
principal investigator · University of Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Coenzyme Q10

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