Muscle FunctionPhase 215CAHLNCT02317536
A Pilot Clinical Trial on the Efficacy of Two Carnitine-Based Products on Muscle Function in Healthy Older Adults
A Phase 2 study testing Carnipure Product 1 and Carnipure Product 2 in people with Muscle Function, run by KGK Science Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Function
- What is being tested?
- Carnipure Product 1 and Carnipure Product 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Muscle Function
- Being tested
- Carnipure Product 1, Carnipure Product 2, Placebo
- Keywords
- Muscle function, L-Carnitine, Carnipure, DXA, anabolism, 6 minute walk, dynamometry, muscle biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carnipure Product 1Dietary supplement
Carnipure Product 2Dietary supplement
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Carnipure Product 1 | Experimental | Carnitine-based product 1, subjects will take one dose once daily for 56 days. Receives: Dietary Supplement: Carnipure Product 1 |
| Carnipure Product 2 | Experimental | Carnitine-based product 2, subjects will take one dose once daily for 56 days. Receives: Dietary Supplement: Carnipure Product 2 |
| Placebo | Placebo comparator | Placebo, subjects will take one dose once daily for 56 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 57
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: Baseline and Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lonza Inc.
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317536
- Sponsor's protocol ID
- 15CAHL
- Acronym
- 15CAHL
- Status last verified
- Sep 2015
- First submitted
- 11 Dec 2014
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02317536
- Acronym / sponsor ID
- 15CAHL / 15CAHL
- Conditions
- Muscle Function
- Keywords
- Muscle function, L-Carnitine, Carnipure, DXA, anabolism, 6 minute walk, dynamometry, muscle biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lonza Inc.
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carnipure Product 1 | Experimental | Dietary Supplement: Carnipure Product 1Carnitine-based product 1, subjects will take one dose once daily for 56 days. |
| Carnipure Product 2 | Experimental | Dietary Supplement: Carnipure Product 2Carnitine-based product 2, subjects will take one dose once daily for 56 days. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, subjects will take one dose once daily for 56 days. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carnipure Product 1 | Dietary supplement | Carnipure Product 1 |
| Carnipure Product 2 | Dietary supplement | Carnipure Product 2 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetyana Pelipyagina, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carnipure Product 1 and Carnipure Product 2 in people with Muscle Function, run by KGK Science Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.