Carnitine Supplementation and Skeletal Muscle Function

NCT ID: NCT02692235

Last Updated: 2019-05-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-07-31

Brief Summary

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Research project objectives The primary aim of the current research project is to use carnitine supplementation as the anti-inflammatory intervention for exploring the relationship between inflammation and associated with aging reduction of skeletal muscle mass.

Hypothesis The carnitine supplementation modulates the blood cytokines concentration. Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated with aging

Detailed Description

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Volunteers over 65 years old (n=40) are supplemented either with carnitine or placebo for 24 weeks. Before the start, in the mid-point, and after finishing the supplementation the following primary outputs variables are performed: body composition analysis (InBody720), maximal isokinetic knee extensor peak torque (Biodex System 4 Pro), blood cytokines and carnitine concentration, blood lipid profile.

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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carnitine

24 weeks l-carnitine-l-tartrate supplementation

Group Type EXPERIMENTAL

carnitine

Intervention Type DIETARY_SUPPLEMENT

1500 mg/d l-carnitine-l-tartrate

placebo

24 weeks isonitrogenous supplementation

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

isonitrogenous

Interventions

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carnitine

1500 mg/d l-carnitine-l-tartrate

Intervention Type DIETARY_SUPPLEMENT

placebo

isonitrogenous

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Subjects with no history of gastrointestinal disorders, cardiovascular disease or hypertension.

Exclusion Criteria

* Subjects having any illnesses and a history of gastrointestinal disorder, cardiovascular disease, hypertension, liver and renal disease, diabetes, cancer, alcoholism or other metabolic diseases.
Minimum Eligible Age

65 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Science Centre, Poland

OTHER_GOV

Sponsor Role collaborator

Gdansk University of Physical Education and Sport

OTHER

Sponsor Role lead

Responsible Party

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Robert Olek

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert A Olek, PhD

Role: PRINCIPAL_INVESTIGATOR

Gdansk University of Physical Education and Sport

Locations

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University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Countries

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Poland

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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2014/15/B/NZ7/00893

Identifier Type: -

Identifier Source: org_study_id

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