Clinical trial NCT02317536: A Pilot Clinical Trial on the Efficacy of Two Carnitine-Based Products on Muscle Function in Healthy Older Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Function
Keywords: Muscle function
L-Carnitine
Carnipure
DXA
anabolism
6 minute walk
dynamometry
muscle biopsy
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Lonza Inc.
First posted: 2014-12-16
Enrollment: 42
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 2 versus those administered Placebo
timeFrame: Baseline and Day 57
Secondary outcomes:
measure: Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
timeFrame: Baseline and Day 57
measure: Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
timeFrame: Baseline and Day 57
measure: Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
timeFrame: Baseline and Day 57
measure: Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
timeFrame: Baseline and Day 57
measure: Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
timeFrame: Baseline and Day 57
Other outcomes:
measure: Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 2 versus Placebo
timeFrame: Baseline and Day 57
measure: Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 1 versus those administered Placebo
timeFrame: Baseline and Day 57
measure: Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 1 versus those administered Carnipure Product 2
timeFrame: Baseline and Day 57
measure: Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
timeFrame: Baseline and Day 57
measure: Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
timeFrame: Baseline and Day 57
measure: Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
timeFrame: Baseline to Day 57
measure: Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
timeFrame: Baseline and Day 57
measure: Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
timeFrame: Baseline and Day 57
measure: Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
timeFrame: Baseline and Day 57
measure: Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
timeFrame: Baseline and Day 57
measure: Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
timeFrame: Baseline and Day 57
measure: Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
timeFrame: Baseline and Day 57
measure: Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
timeFrame: Baseline and Day 57
measure: Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 1 versus Placebo
timeFrame: Baseline and Day 57
measure: Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 1 versus Carnipure Product 2
timeFrame: Baseline and Day 57
measure: Changes in vital signs from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
timeFrame: Screening to Day 57
measure: Changes in vital signs from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
timeFrame: Screening to Day 57
measure: Changes in vital signs from screening to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
timeFrame: Screening to Day 57
measure: Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo
timeFrame: Screening and Day 57
measure: Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo
timeFrame: Screening and Day 57
measure: Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
timeFrame: Screening and Day 57
measure: Number of adverse events experienced in subjects administered Carnipure Product 2 versus those administered Placebo
timeFrame: 57 days
measure: Number of adverse events experienced in subjects administered Carnipure Product 1 versus those administered Placebo
timeFrame: 57 days
measure: Number of adverse events experienced in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2
timeFrame: 57 days
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Tetyana Pelipyagina, MD
role: PRINCIPAL_INVESTIGATOR
References: