Carnitine Supplementation and Skeletal Muscle Function
1 other identifier
interventional
28
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 13, 2016
CompletedFirst Posted
Study publicly available on registry
February 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedResults Posted
Study results publicly available
May 9, 2019
CompletedMay 23, 2019
May 1, 2019
1.1 years
February 13, 2016
July 17, 2017
May 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Inflammatory Marker
Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)
baseline and after 24 weeks of supplementation period
Secondary Outcomes (1)
Lipid Metabolites
baseline and after 24 weeks of supplementation period
Study Arms (2)
carnitine
EXPERIMENTAL24 weeks l-carnitine-l-tartrate supplementation
placebo
PLACEBO COMPARATOR24 weeks isonitrogenous supplementation
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with no history of gastrointestinal disorders, cardiovascular disease or hypertension.
You may not qualify if:
- Subjects having any illnesses and a history of gastrointestinal disorder, cardiovascular disease, hypertension, liver and renal disease, diabetes, cancer, alcoholism or other metabolic diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Olek
- Organization
- AWFiS
Study Officials
- PRINCIPAL INVESTIGATOR
Robert A Olek, PhD
Gdansk University of Physical Education and Sport
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
February 13, 2016
First Posted
February 26, 2016
Study Start
February 1, 2016
Primary Completion
March 1, 2017
Study Completion
July 1, 2017
Last Updated
May 23, 2019
Results First Posted
May 9, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share