- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03418376
Carnosine Loading and Periodized Training in MS and HC
The Impact of Carnosine Loading and Rehabilitation Therapy on Exercise Capacity in Multiple Sclerosis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pilot data from the (co-)applicants' laboratories suggest that EAE rats (animal MS model) and MS-patients suffer from significantly reduced muscle carnosine levels compared to healthy counterparts. The potential of β-alanine supplementation to elevate muscle carnosine content has been shown in healthy volunteers. Furthermore, the investigators have recently investigated β-alanine and carnosine supplementation in EAE animals. In MS, this has not been investigated yet. Therefore, the researchers' next step is to investigate the impact of β-alanine intake on exercise performance in MS patients. The investigators hypothesize that oral β-alanine supplementation improves exercise therapy outcomes in MS patients.
So far, it is clear that β-alanine intake enhances exercise capacity of untrained, trained and aged individuals by improving contractile properties, maintaining higher intracellular energy levels and optimizing training adaptations. Because early fatigue of contracting musculature during rehabilitation is the predominant cause of exercise cessation, postponing exercise-induced fatigue by β-alanine supplementation will be clinically very relevant (improving exercise therapy efficiency). Consequently, the investigators aim to research the ergogenic potential of β-alanine intake in MS rehabilitation and hypothesize that β-alanine supplementation optimizes exercise therapy outcome (exercise capacity, muscle contractile characteristics) in this population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
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Diepenbeek, Limburg, Belgium, 3590
- Hasselt University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
Diagnosis Multiple Sclerosis. Healthy control. Aged >18y. Written informed consent.
Exclusion criteria:
Contraindications to perform moderate to high intensity exercise. Participation in another study. Experienced acute MS related exacerbation <6 months prior to start of the study EDSS score > 3.5
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MS beta-alanine supplementation
Subjects will perform a 6-month exercise intervention and receive beta-alanine supplements.
|
The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks.
After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.
The exercise training program (6 months) involves 3 week cycles (week I-III).
During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week).
Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax).
During week II, subjects will perform low volume maximum intensity interval cycle training (3/w).
High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals.
A 5min standardized warming up and 5min cooling down will be performed.
Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT.
|
Placebo Comparator: MS placebo group
Subjects will perform a 6-month exercise intervention and receive placebo tablets.
|
The exercise training program (6 months) involves 3 week cycles (week I-III).
During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week).
Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax).
During week II, subjects will perform low volume maximum intensity interval cycle training (3/w).
High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals.
A 5min standardized warming up and 5min cooling down will be performed.
Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT.
|
Experimental: HC beta-alanine supplementation
Subjects will perform a 6-month exercise intervention and receive beta-alanine supplements.
|
The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks.
After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.
The exercise training program (6 months) involves 3 week cycles (week I-III).
During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week).
Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax).
During week II, subjects will perform low volume maximum intensity interval cycle training (3/w).
High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals.
A 5min standardized warming up and 5min cooling down will be performed.
Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT.
|
Placebo Comparator: HC placebo group
Subjects will perform a 6-month exercise intervention and receive placebo tablets.
|
The exercise training program (6 months) involves 3 week cycles (week I-III).
During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week).
Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax).
During week II, subjects will perform low volume maximum intensity interval cycle training (3/w).
High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals.
A 5min standardized warming up and 5min cooling down will be performed.
Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2max
Time Frame: Before and after 6 months training (pre vs post)
|
Exercise capacity will be assessed using a maximal (12-lead ECG) graded cardiopulmonary exercise test (♂: 30W+15W/min, ♀: 20W+10W/min, GE eBike Basic®) with pulmonary gas exchange analysis (Jaeger Oxycon®).
VO2max (maximal oxygen uptake) will be monitored.
This test will be performed at least 48 hours separated from the muscle strength test, to prevent interference of muscle fatigue.
Respiratory exchange ratio (RER) values will be evaluated to verify if the test was performed maximally (RER >1.1).
|
Before and after 6 months training (pre vs post)
|
Serum Lactate
Time Frame: Before and after 6 months training (pre vs post)
|
During the exercise test, 2min capillary blood samples will be obtained to analyse blood lactate concentrations (Analox®) and determine the anaerobic threshold before, during and after exercise.
Lactate max levels are the maximal concentrations measured during the test, whilst peak Lactate are the lactate concentrations following 2 minutes of rest after cessation of the maximal exercise test.
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Before and after 6 months training (pre vs post)
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Body Composition
Time Frame: Before and after 6 months training (pre vs post)
|
Whole body fat and lean tissue mass will be obtained using Dual Energy X-ray Absorptiometry scan (DEXA) (Hologic Series Delphi-A Fan Beam X-ray Bone Densitometer, Vilvoorde, Belgium).
A calibrated analogue weight balance (Seca®) will be used to measure total body mass.
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Before and after 6 months training (pre vs post)
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Strength Assessment Core Musculature
Time Frame: Before and after 6 months training (pre vs post)
|
Back- and abdominal muscle strength will be assessed using an isokinetic dynamometer (System 3, Biodex, ENRAF-NONIUS, New York, USA).
After adequate warming-up and movement familiarization, subjects will perform 3 maximal isometric contractions of back- and abdominal muscles for 4-5sec.
The peak value of the 3 maximal contractions will be reported (peak back, and peak abdominal muscles).
|
Before and after 6 months training (pre vs post)
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Workload
Time Frame: Before and after 6 months training (pre vs post)
|
Exercise capacity will be assessed using a maximal (12-lead ECG) graded cardiopulmonary exercise test (♂: 30W+15W/min, ♀: 20W+10W/min, GE eBike Basic®) with pulmonary gas exchange analysis (Jaeger Oxycon®).
VO2max (maximal oxygen uptake) will be monitored.
This test will be performed at least 48 hours separated from the muscle strength test, to prevent interference of muscle fatigue.
Respiratory exchange ratio (RER) values will be evaluated to verify if the test was performed maximally (RER >1.1).
|
Before and after 6 months training (pre vs post)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bert O Eijnde, Hasselt University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17.09/REVA17.02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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