The Impact of Carnosine Loading and Rehabilitation Therapy on Exercise Capacity in Multiple Sclerosis.

CompletedNot a drug-phase studyMS (type not specified)NCT03418376

What it found

Results posted, not judged

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)

GroupValueIntervalNumber analysed
MS Beta-alanine Supplementation40.4 ml/kg/min6.5 (Standard Deviation)11
MS Placebo Group41.2 ml/kg/min7.9 (Standard Deviation)6
HC Beta-alanine Supplementation44 ml/kg/min8.7 (Standard Deviation)8
HC Placebo Group43.4 ml/kg/min8.6 (Standard Deviation)10

MS Beta-alanine Supplementation

40.4

MS Placebo Group

41.2

HC Beta-alanine Supplementation

44

HC Placebo Group

43.4

Serum Lactate

Before and after 6 months training (pre vs post)

GroupValueIntervalNumber analysed
MS Beta-alanine Supplementation4.6 mmol/L2 (Standard Deviation)11
MS Placebo Group4.4 mmol/L0.4 (Standard Deviation)6
HC Beta-alanine Supplementation5.0 mmol/L1.2 (Standard Deviation)8
HC Placebo Group5.1 mmol/L0.9 (Standard Deviation)10
MS Beta-alanine Supplementation8.5 mmol/L2.6 (Standard Deviation)11
MS Placebo Group9.2 mmol/L1 (Standard Deviation)6
HC Beta-alanine Supplementation10.6 mmol/L2.6 (Standard Deviation)8
HC Placebo Group8.9 mmol/L2.3 (Standard Deviation)10

Body Composition

Before and after 6 months training (pre vs post)

GroupValueIntervalNumber analysed
MS Beta-alanine Supplementation51.4 kg7 (Standard Deviation)11
MS Placebo Group49.2 kg8.4 (Standard Deviation)6
HC Beta-alanine Supplementation55.7 kg7.7 (Standard Deviation)8
HC Placebo Group50.3 kg10.8 (Standard Deviation)10
MS Beta-alanine Supplementation16.8 kg9.7 (Standard Deviation)11
MS Placebo Group15.5 kg6.6 (Standard Deviation)6
HC Beta-alanine Supplementation14.6 kg5.8 (Standard Deviation)8
HC Placebo Group16.5 kg5.2 (Standard Deviation)10

Strength Assessment Core Musculature

Before and after 6 months training (pre vs post)

GroupValueIntervalNumber analysed
MS Beta-alanine Supplementation257.4 Nm66.2 (Standard Deviation)11
MS Placebo Group243.3 Nm80.3 (Standard Deviation)6
HC Beta-alanine Supplementation243.5 Nm54.4 (Standard Deviation)8
HC Placebo Group256 Nm87.7 (Standard Deviation)10
MS Beta-alanine Supplementation132.7 Nm28.9 (Standard Deviation)11
MS Placebo Group145.3 Nm42.8 (Standard Deviation)6
HC Beta-alanine Supplementation141 Nm35.9 (Standard Deviation)8
HC Placebo Group149.5 Nm46.6 (Standard Deviation)10

Workload

Before and after 6 months training (pre vs post)

GroupValueIntervalNumber analysed
MS Beta-alanine Supplementation209 Wattage45 (Standard Deviation)11
MS Placebo Group212 Wattage41 (Standard Deviation)6
HC Beta-alanine Supplementation248 Wattage44 (Standard Deviation)8
HC Placebo Group235 Wattage59 (Standard Deviation)10

MS Beta-alanine Supplementation

209

MS Placebo Group

212

HC Beta-alanine Supplementation

248

HC Placebo Group

235

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
MS Beta-alanine Supplementation120 (0.0%)0
MS Placebo Group110 (0.0%)0
HC Beta-alanine Supplementation110 (0.0%)0
HC Placebo Group110 (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 function
  • Serum Lactate

    Before and after 6 months training (pre vs post)

    Physical function
  • Body Composition

    Before and after 6 months training (pre vs post)

    Walking and mobilityPhysical function
  • Strength Assessment Core Musculature

    Before and after 6 months training (pre vs post)

    Physical function
  • Workload

    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

    1. Started

      Feb 2017

    2. Main results due

      Oct 2017

    3. Finished

      Dec 2017

    4. Results posted

      Apr 2020

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