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

Muscle Function Clinical Trial

— 15CAHL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317536
• Other study ID #: 15CAHL
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2014
• Last updated: September 17, 2015
• Start date: December 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Muscle Function

Intervention

Dietary Supplement:
• Carnipure Product 1

• Carnipure Product 2

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	Lonza Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 2 versus Placebo	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	No
Other	Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 1 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	No
Other	Percent Change in Muscle Function Composite Endpoint from Baseline to Day 57 of subjects administer Carnipure Product 1 versus those administered Carnipure Product 2	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	No
Other	Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo	Lean Body Mass measured by DXA scan	Baseline and Day 57	No
Other	Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2	Lean Body Mass measured by DXA scan	Baseline and Day 57	No
Other	Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 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 to Day 57	No
Other	Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2	Functional lower body strength will be determined using a hand-held dynamometer to measure leg extension resistance (kg of resistance).	Baseline and Day 57	No
Other	Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 1 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	No
Other	Changes in functional upper body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2	Functional upper body strength will be determined using a grip strength dynamometer to measure grip strength resistance (kg of resistance).	Baseline and Day 57	No
Other	Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 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	No
Other	Changes in functional lower body strength from baseline to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2	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	No
Other	Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo	Assessed using the RAND SF-36 questionnaire	Baseline and Day 57	No
Other	Changes in Quality of Life questionnaire score from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2	Assessed using the RAND SF-36 questionnaire	Baseline and Day 57	No
Other	Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 1 versus Placebo	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	No
Other	Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 1 versus Carnipure Product 2	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	No
Other	Changes in vital signs from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo	Blood pressure, heart rate, BMI, electrocardiogram	Screening to Day 57	Yes
Other	Changes in vital signs from baseline to day 57 in subjects administered Carnipure Product 1 versus those administered Placebo	Blood pressure, heart rate, BMI, electrocardiogram	Screening to Day 57	Yes
Other	Changes in vital signs from screening to day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2	Blood pressure, heart rate, BMI, electrocardiogram	Screening to Day 57	Yes
Other	Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 2 versus those administered Placebo	CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin	Screening and Day 57	Yes
Other	Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 1 versus those administered Placebo	CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin	Screening and Day 57	Yes
Other	Changes in hematology and clinical chemistry from screening to Day 57 in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2	CBC, electrolytes, glucose, creatinine, AST, ALT, GGT, bilirubin	Screening and Day 57	Yes
Other	Number of adverse events experienced in subjects administered Carnipure Product 2 versus those administered Placebo		57 days	Yes
Other	Number of adverse events experienced in subjects administered Carnipure Product 1 versus those administered Placebo		57 days	Yes
Other	Number of adverse events experienced in subjects administered Carnipure Product 1 versus those administered Carnipure Product 2		57 days	Yes
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No