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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Muscle Function

Intervention / Treatment
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* Dietary Supplement: Carnipure Product 1
* Dietary Supplement: Carnipure Product 2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carnipure Product 1<br>Carnitine-based product 1, subjects will take one dose once daily for 56 days. | Dietary Supplement: Carnipure Product 1<br> <br> |
| Experimental: Carnipure Product 2<br>Carnitine-based product 2, subjects will take one dose once daily for 56 days. | Dietary Supplement: Carnipure Product 2<br> <br> |
| Placebo Comparator: Placebo<br>Placebo, subjects will take one dose once daily for 56 days. | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| 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 | 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

| 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 | 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 | 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 | 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 | 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 | Lean Body Mass measured by DXA scan | Baseline and Day 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle function, L-Carnitine, Carnipure, DXA, anabolism, 6 minute walk, dynamometry, muscle biopsy