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

NCT02317536 | Completed Phase 2

• 1 other identifier: 15CAHL
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Function

Keywords

Muscle function; L-Carnitine; Carnipure; DXA; anabolism; 6 minute walk; dynamometry; muscle biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• Changes in Lean Body Mass from baseline to day 57 in subjects administered Carnipure Product 2 versus those administered Placebo

  Baseline and Day 57

Other Outcomes (24)

• Changes in muscle metabolism from baseline to day 57 in subjects administered Carnipure Product 2 versus Placebo

  Baseline and Day 57

• 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

• 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

Study Arms (3)

Carnipure Product 1

EXPERIMENTAL

Carnitine-based product 1, subjects will take one dose once daily for 56 days.

Dietary Supplement: Carnipure Product 1

Carnipure Product 2

EXPERIMENTAL

Carnitine-based product 2, subjects will take one dose once daily for 56 days.

Dietary Supplement: Carnipure Product 2

Placebo

PLACEBO COMPARATOR

Placebo, subjects will take one dose once daily for 56 days.

Other: Placebo

Interventions

Carnipure Product 1 DIETARY_SUPPLEMENT

Carnipure Product 1

Carnipure Product 2 DIETARY_SUPPLEMENT

Carnipure Product 2

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• KGK Science Inc.: lead
• Lonza Inc.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 16, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

CA (1)