A Pilot Clinical Trial on the Efficacy of Two Carnitine-Based Products on Muscle Function in Healthy Older Adults (15CAHL)

September 17, 2015 updated by: KGK Science Inc.

A Randomized Double-Blind, Placebo-Controlled Pilot Clinical Trial to Evaluate the Relative Efficacy of Two Carnitine-Based Products Purported to Promote Muscle Anabolism in Healthy Older Adults

This study evaluates two L-Carnitine-based products on muscle function in healthy older adults (55 to 70 years old). These products are suspected to improve muscle function and possibly promote building of muscle mass. One third of the subjects will be on Carnipure Product 1, one third will be on Carnipure Product 2 and one third will be on placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5R8
        • KGK Synergize Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female adults, aged 55 to 70 years
  • BMI of 21 kg/m2 to 33 kg/m2
  • Subjects in good physical condition such that they can perform exercise testing safely, as determined by the Qualified Investigator based on medical history, physical examination, electrocardiogram and laboratory results
  • Subjects who are sedentary and not currently engaging in any regular exercise.
  • Subjects who agree to maintain their current level of activity and current dietary habits throughout the trial period.
  • Subjects who have given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

  • Subjects who are smokers or have been a smoker within the past 1 year from screening.
  • Subjects who are pregnant or breastfeeding
  • Subjects who have experienced weight loss or gain of greater than 4.5 kg (approximately 10 lbs) within 3 months of randomization
  • Subjects diagnosed with active heart disease
  • Subjects with uncontrolled hypertension (≥ 140 mmHg)
  • Subjects with renal or hepatic impairment or disease
  • Subjects with any major diseases of the gastrointestinal, pulmonary or endocrine systems
  • Subjects with a history of seizures
  • Subjects with Type I or Type II Diabetes
  • Subjects with active cancer (excluding basal cell carcinoma)
  • Subjects with neurological or significant psychiatric illnesses, including Parkinson's disease and bi-polar disorder
  • Subjects with unstable thyroid disease
  • Subjects who are immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis)
  • Subjects with metal fixation plates or screws from a previous surgery
  • Subjects who are taking oral anticoagulants (blood thinners) such as warfarin (Coumadin) or Dabigatran (Pradaxa) or antiplatelet agents such as Clopidogrel (Plavix)
  • Subjects who are regularly taking NSAID medications such as aspirin, must stop at least one week prior to the micro-needle muscle biopsy procedures.
  • Subjects with a known allergy to anesthetic
  • Subjects who currently experience any medical condition that interferes with the ability to undergo physical strength testing during the study
  • Subjects currently taking NHPs must have been using their current dosing regimen for at least one month prior to baseline and must maintain their current dosing regimen throughout the trial and must not begin taking any new NHPs throughout the trial. If the subject wishes to stop taking the NHP prior to beginning the trial, they must do so at least 1 week prior to randomization.
  • Subjects who use illicit drugs or have a history of alcohol or drug abuse within the past 6 months
  • Subjects who currently consume greater than 2 standard alcoholic drinks per day.
  • Subjects who have participated in a clinical research trial within 30 days prior to randomization.
  • Subjects with an allergy or sensitivity to the investigational product ingredient.
  • Subjects who are cognitively impaired and/or who are unable to give informed consent
  • Subjects who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the Qualified Investigator, may adversely affect the subjects ability to complete the study or its measures or which may pose significant risk to the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Carnipure Product 1
Carnitine-based product 1, subjects will take one dose once daily for 56 days.
Dietary supplement: Carnipure Product 1
Experimental: Carnipure Product 2
Carnitine-based product 2, subjects will take one dose once daily for 56 days.
Dietary supplement: Carnipure Product 2
Placebo Comparator: Placebo
Placebo, subjects will take one dose once daily for 56 days.
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 2 versus those administered Placebo
Time Frame: Baseline and Day 57
A composite endpoint determined by multiplying the values of Lean Body Mass (as assessed by DXA, kg), and functional muscle strength (as assessed by 6 Minute Walk Test, metres; Lower Body Dynamometry, kg; Upper Body Dynamometry, kg). Percent change from baseline to day 57 will be derived.
Baseline and Day 57

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Time Frame: Baseline and Day 57
Functional lower body strength will be determined using a hand-held dynamometer to measure leg extension resistance (kg of resistance).
Baseline and Day 57
Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Time Frame: Baseline and Day 57
Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance).
Baseline and Day 57
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Time Frame: Baseline and Day 57
Functional lower body strength will be assessed using the 6 Minute Walk Test to determine the distance walked over 6 minutes (metres).
Baseline and Day 57
Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Time Frame: Baseline and Day 57
Assessed using the RAND SF-36 questionnaire
Baseline and Day 57
Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Time Frame: Baseline and Day 57
Lean Body Mass measured by DXA scan
Baseline and Day 57

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 2 versus Placebo
Time Frame: Baseline and Day 57
Assessed by laboratory analysis of muscle biopsy samples collected at baseline (pre-strength testing) and Day 57 (pre and post-strength testing)
Baseline and Day 57
Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 1 versus those administered Placebo
Time Frame: Baseline and Day 57
A composite endpoint determined by multiplying the values of Lean Body Mass (as assessed by DXA, kg), and functional muscle strength (as assessed by 6 Minute Walk Test, metres; Lower Body Dynamometry, kg; Upper Body Dynamometry, kg). Percent change from baseline to day 57 will be derived.
Baseline and Day 57
Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 1 versus those administered Carnipure Product 2
Time Frame: Baseline and Day 57
A composite endpoint determined by multiplying the values of Lean Body Mass (as assessed by DXA, kg), and functional muscle strength (as assessed by 6 Minute Walk Test, metres; Lower Body Dynamometry, kg; Upper Body Dynamometry, kg). Percent change from baseline to day 57 will be derived.
Baseline and Day 57
Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
Time Frame: Baseline and Day 57
Lean Body Mass measured by DXA scan
Baseline and Day 57
Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
Time Frame: Baseline and Day 57
Lean Body Mass measured by DXA scan
Baseline and Day 57
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
Time Frame: Baseline to Day 57
Functional lower body strength will be determined using a hand-held dynamometer to measure leg extension resistance (kg of resistance).
Baseline to Day 57
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
Time Frame: Baseline and Day 57
Functional lower body strength will be determined using a hand-held dynamometer to measure leg extension resistance (kg of resistance).
Baseline and Day 57
Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
Time Frame: Baseline and Day 57
Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance).
Baseline and Day 57
Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
Time Frame: Baseline and Day 57
Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance).
Baseline and Day 57
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
Time Frame: Baseline and Day 57
Functional lower body strength will be assessed using the 6 Minute Walk Test to determine the distance walked over 6 minutes (metres).
Baseline and Day 57
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
Time Frame: Baseline and Day 57
Functional lower body strength will be assessed using the 6 Minute Walk Test to determine the distance walked over 6 minutes (metres).
Baseline and Day 57
Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
Time Frame: Baseline and Day 57
Assessed using the RAND SF-36 questionnaire
Baseline and Day 57
Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
Time Frame: Baseline and Day 57
Assessed using the RAND SF-36 questionnaire
Baseline and Day 57
Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 1 versus Placebo
Time Frame: Baseline and Day 57
Assessed by laboratory analysis of muscle biopsy samples collected at baseline (pre-strength testing) and Day 57 (pre and post-strength testing)
Baseline and Day 57
Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 1 versus Carnipure Product 2
Time Frame: Baseline and Day 57
Assessed by laboratory analysis of muscle biopsy samples collected at baseline (pre-strength testing) and Day 57 (pre and post-strength testing)
Baseline and Day 57
Changes in vital signs from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Time Frame: Screening to Day 57
Blood pressure, heart rate, BMI, electrocardiogram
Screening to Day 57
Changes in vital signs from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
Time Frame: Screening to Day 57
Blood pressure, heart rate, BMI, electrocardiogram
Screening to Day 57
Changes in vital signs from screening to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
Time Frame: Screening to Day 57
Blood pressure, heart rate, BMI, electrocardiogram
Screening to Day 57
Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
Time Frame: Screening and Day 57
CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin
Screening and Day 57
Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
Time Frame: Screening and Day 57
CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin
Screening and Day 57
Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
Time Frame: Screening and Day 57
CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin
Screening and Day 57
Number of adverse events experienced in subjects administered Carnipure Product 2 versus those administered Placebo
Time Frame: 57 days
57 days
Number of adverse events experienced in subjects administered Carnipure Product 1 versus those administered Placebo
Time Frame: 57 days
57 days
Number of adverse events experienced in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
Time Frame: 57 days
57 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KGK Science Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lonza Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15CAHL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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