CoQ10 in Statin-associated Asthenia

NCT ID: NCT06391606

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesterolemia Physical Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Coenzyme Q10

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

Group Type ACTIVE_COMPARATOR

Coenzyme Q10

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

2 pills of placebo per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2 pills/day

Interventions

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Coenzyme Q10

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 pills/day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Claudio Borghi

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudio Borghi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Locations

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University of Bologna

Bologna, BO, Italy

Site Status

Countries

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Italy

Other Identifiers

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QELD_Stat_2017

Identifier Type: -

Identifier Source: org_study_id

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