Carnosine Loading and Periodized Training in MS and HC
The Impact of Carnosine Loading and Rehabilitation Therapy on Exercise Capacity in Multiple Sclerosis.
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Beta-alanine supplementation
Given to everyone in the trial
- Exercise intervention
Results by group
VO2max
Before and after 6 months training (pre vs post)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS Beta-alanine Supplementation | 40.4 ml/kg/min | 6.5 (Standard Deviation) | 11 |
| MS Placebo Group | 41.2 ml/kg/min | 7.9 (Standard Deviation) | 6 |
| HC Beta-alanine Supplementation | 44 ml/kg/min | 8.7 (Standard Deviation) | 8 |
| HC Placebo Group | 43.4 ml/kg/min | 8.6 (Standard Deviation) | 10 |
MS Beta-alanine Supplementation
MS Placebo Group
HC Beta-alanine Supplementation
HC Placebo Group
Serum Lactate
Before and after 6 months training (pre vs post)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS Beta-alanine Supplementation | 4.6 mmol/L | 2 (Standard Deviation) | 11 |
| MS Placebo Group | 4.4 mmol/L | 0.4 (Standard Deviation) | 6 |
| HC Beta-alanine Supplementation | 5.0 mmol/L | 1.2 (Standard Deviation) | 8 |
| HC Placebo Group | 5.1 mmol/L | 0.9 (Standard Deviation) | 10 |
| MS Beta-alanine Supplementation | 8.5 mmol/L | 2.6 (Standard Deviation) | 11 |
| MS Placebo Group | 9.2 mmol/L | 1 (Standard Deviation) | 6 |
| HC Beta-alanine Supplementation | 10.6 mmol/L | 2.6 (Standard Deviation) | 8 |
| HC Placebo Group | 8.9 mmol/L | 2.3 (Standard Deviation) | 10 |
Body Composition
Before and after 6 months training (pre vs post)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS Beta-alanine Supplementation | 51.4 kg | 7 (Standard Deviation) | 11 |
| MS Placebo Group | 49.2 kg | 8.4 (Standard Deviation) | 6 |
| HC Beta-alanine Supplementation | 55.7 kg | 7.7 (Standard Deviation) | 8 |
| HC Placebo Group | 50.3 kg | 10.8 (Standard Deviation) | 10 |
| MS Beta-alanine Supplementation | 16.8 kg | 9.7 (Standard Deviation) | 11 |
| MS Placebo Group | 15.5 kg | 6.6 (Standard Deviation) | 6 |
| HC Beta-alanine Supplementation | 14.6 kg | 5.8 (Standard Deviation) | 8 |
| HC Placebo Group | 16.5 kg | 5.2 (Standard Deviation) | 10 |
Strength Assessment Core Musculature
Before and after 6 months training (pre vs post)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS Beta-alanine Supplementation | 257.4 Nm | 66.2 (Standard Deviation) | 11 |
| MS Placebo Group | 243.3 Nm | 80.3 (Standard Deviation) | 6 |
| HC Beta-alanine Supplementation | 243.5 Nm | 54.4 (Standard Deviation) | 8 |
| HC Placebo Group | 256 Nm | 87.7 (Standard Deviation) | 10 |
| MS Beta-alanine Supplementation | 132.7 Nm | 28.9 (Standard Deviation) | 11 |
| MS Placebo Group | 145.3 Nm | 42.8 (Standard Deviation) | 6 |
| HC Beta-alanine Supplementation | 141 Nm | 35.9 (Standard Deviation) | 8 |
| HC Placebo Group | 149.5 Nm | 46.6 (Standard Deviation) | 10 |
Workload
Before and after 6 months training (pre vs post)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS Beta-alanine Supplementation | 209 Wattage | 45 (Standard Deviation) | 11 |
| MS Placebo Group | 212 Wattage | 41 (Standard Deviation) | 6 |
| HC Beta-alanine Supplementation | 248 Wattage | 44 (Standard Deviation) | 8 |
| HC Placebo Group | 235 Wattage | 59 (Standard Deviation) | 10 |
MS Beta-alanine Supplementation
MS Placebo Group
HC Beta-alanine Supplementation
HC Placebo Group
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| MS Beta-alanine Supplementation | 12 | 0 (0.0%) | 0 |
| MS Placebo Group | 11 | 0 (0.0%) | 0 |
| HC Beta-alanine Supplementation | 11 | 0 (0.0%) | 0 |
| HC Placebo Group | 11 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
VO2max
Before and after 6 months training (pre vs post)
FatiguePhysical functionSerum Lactate
Before and after 6 months training (pre vs post)
Physical functionBody Composition
Before and after 6 months training (pre vs post)
Walking and mobilityPhysical functionStrength Assessment Core Musculature
Before and after 6 months training (pre vs post)
Physical functionWorkload
Before and after 6 months training (pre vs post)
FatiguePhysical function
Who could take part
MS (type not specified) · 18 to 75
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Increasing evidence favours exercise therapy as an efficient tool to counteract inactivity related secondary symptoms in MS. Furthermore, exercise therapy may affect MS-associated muscle contractile and energy supply dysfunctions. So far, low to moderate intensity exercise rehabilitation has shown to induce small but consistent improvements in several functional parameters. High intensity exercise training in MS seems to further improve this. However, although results are promising, impairments in both muscle contraction and energy supply probably attenuate therapy outcome. In keeping with the above described physiological role of skeletal muscle carnosine and because muscle carnosine content may be lower in MS, the primary aim of the present project is to investigate whether carnosine loading improves exercise therapy outcome (exercise capacity, body composition) and performance in MS. If the latter hypothesis can be confirmed, muscle carnosine loading could be a novel intervention to improve exercise capacity and muscle function in this population.
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History
Started
Feb 2017
Main results due
Oct 2017
Finished
Dec 2017
Results posted
Apr 2020