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Completed

NCT Number: NCT06391606

CoQ10 in Statin-associated Asthenia

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.

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Key information

Conditions

Hypercholesterolemia Asthenia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Physical Performance Signs and Symptoms

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bologna

Bologna, BO, 40138, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coenzyme Q10

Dietary Supplement

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

Placebo

Other

2 pills/day

Primary outcomes

  1. Effect on handgrip strength

    Time frame: 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 outcomes

  1. Effect on handgrip strength

    Time frame: 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.

  2. Effect on statin-associated asthenia

    Time frame: 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.

  3. Effect on statin-associated asthenia

    Time frame: 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.

  4. Effect on 1-min sit-to-stand repetitions

    Time frame: 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.

  5. Effect on 1-min sit-to-stand repetitions

    Time frame: 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.

  6. Effect on 2-minute step test

    Time frame: 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.

  7. Effect on 2-minute step test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2024
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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