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

Sponsor

KGK Science Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02317536

Collaborator

Lonza Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Function	Dietary Supplement: Carnipure Product 1 Dietary Supplement: Carnipure Product 2 Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 2 versus those administered Placebo [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.

Secondary Outcome Measures

Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo [Baseline and Day 57]
Functional lower body strength will be determined using a hand-held dynamometer to measure leg extension resistance (kg of resistance).
Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo [Baseline and Day 57]
Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance).
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo [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).
Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo [Baseline and Day 57]
Assessed using the RAND SF-36 questionnaire
Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo [Baseline and Day 57]
Lean Body Mass measured by DXA scan

Other Outcome Measures

Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 2 versus Placebo [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)
Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 1 versus those administered Placebo [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.
Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 1 versus those administered Carnipure Product 2 [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.
Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo [Baseline and Day 57]
Lean Body Mass measured by DXA scan
Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 [Baseline and Day 57]
Lean Body Mass measured by DXA scan
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo [Baseline to Day 57]
Functional lower body strength will be determined using a hand-held dynamometer to measure leg extension resistance (kg of resistance).
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 [Baseline and Day 57]
Functional lower body strength will be determined using a hand-held dynamometer to measure leg extension resistance (kg of resistance).
Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo [Baseline and Day 57]
Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance).
Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 [Baseline and Day 57]
Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance).
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo [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).
Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 [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).
Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo [Baseline and Day 57]
Assessed using the RAND SF-36 questionnaire
Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 [Baseline and Day 57]
Assessed using the RAND SF-36 questionnaire
Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 1 versus Placebo [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)
Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 1 versus Carnipure Product 2 [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)
Changes in vital signs from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo [Screening to Day 57]
Blood pressure, heart rate, BMI, electrocardiogram
Changes in vital signs from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo [Screening to Day 57]
Blood pressure, heart rate, BMI, electrocardiogram
Changes in vital signs from screening to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 [Screening to Day 57]
Blood pressure, heart rate, BMI, electrocardiogram
Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo [Screening and Day 57]
CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin
Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo [Screening and Day 57]
CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin
Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 [Screening and Day 57]
CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin
Number of adverse events experienced in subjects administered Carnipure Product 2 versus those administered Placebo [57 days]
Number of adverse events experienced in subjects administered Carnipure Product 1 versus those administered Placebo [57 days]
Number of adverse events experienced in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2 [57 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.