CoQ10 in Statin-associated Asthenia

University of Bologna60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypercholesterolemia Physical Performance

Interventions

Coenzyme Q10DIETARY_SUPPLEMENT

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

PlaceboOTHER

2 pills/day

Eligibility

Sex: ALLMin age: 65 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Bologna

Bologna, BO, Italy

Outcomes

Primary Outcomes

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

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

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

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

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

Data from ClinicalTrials.gov

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