Back to resultsCarnitine Supplementation and Skeletal Muscle Function
Primary Purpose
Sarcopenia
Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
carnitine
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring carnitine
Eligibility Criteria
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.
Sites / Locations
- University of Physical Education and Sport
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
carnitine
placebo
Arm Description
24 weeks l-carnitine-l-tartrate supplementation
24 weeks isonitrogenous supplementation
Outcomes
Primary Outcome Measures
Blood Inflammatory Marker
Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)
Secondary Outcome Measures
Lipid Metabolites
Change in serum lipid metabolites: total cholesterol (TCh), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG) determined by standard automatic analyzer Cobas 6000 (Roche Diagnostics, Mannheim, Germany)
Full Information
NCT ID
NCT02692235
First Posted
February 13, 2016
Last Updated
May 9, 2019
Sponsor
Gdansk University of Physical Education and Sport
Collaborators
National Science Centre, Poland
1. Study Identification
Unique Protocol Identification Number
NCT02692235
Brief Title
Carnitine Supplementation and Skeletal Muscle Function
Official Title
Carnitine Supplementation and Skeletal Muscle Function in Aging
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gdansk University of Physical Education and Sport
Collaborators
National Science Centre, Poland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
carnitine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
carnitine
Arm Type
Experimental
Arm Description
24 weeks l-carnitine-l-tartrate supplementation
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
24 weeks isonitrogenous supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
carnitine
Intervention Description
1500 mg/d l-carnitine-l-tartrate
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
isonitrogenous
Primary Outcome Measure Information:
Title
Blood Inflammatory Marker
Description
Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)
Time Frame
baseline and after 24 weeks of supplementation period
Secondary Outcome Measure Information:
Title
Lipid Metabolites
Description
Change in serum lipid metabolites: total cholesterol (TCh), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG) determined by standard automatic analyzer Cobas 6000 (Roche Diagnostics, Mannheim, Germany)
Time Frame
baseline and after 24 weeks of supplementation period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Olek, PhD
Organizational Affiliation
Gdansk University of Physical Education and Sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Physical Education and Sport
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-336
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
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Carnitine Supplementation and Skeletal Muscle Function
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