NCT03418376

Carnosine Loading and Periodized Training in MS and HC

Completed NA Results posted Last updated 20 April 2020

What this trial tests

NA trial testing Beta-alanine supplementation in Multiple Sclerosis in 45 participants. Completed in 30 December 2017.

Timeline

1 February 2017

Primary endpoint
30 October 2017

30 December 2017

Quick facts

Lead sponsor	Hasselt University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	45
Start date	1 February 2017
Primary completion	30 October 2017
Estimated completion	30 December 2017
Sites	1 location across Belgium

Drugs / interventions tested

• Beta-alanine supplementation
• Exercise intervention

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Exercise Therapy — all drugs for Exercise Therapy →
• Dietary Supplement — all drugs for Dietary Supplement →

Sponsor

Hasselt University

Who can join

Adults 18 to 75, any sex, with Multiple Sclerosis or Exercise Therapy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

VO2max Primary · 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).

Group	Value	95% CI
MS Beta-alanine Supplementation	40.4	± 6.5
MS Placebo Group	41.2	± 7.9
HC Beta-alanine Supplementation	44	± 8.7
HC Placebo Group	43.4	± 8.6

Serum Lactate Primary · 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.

Lactate max

Group	Value	95% CI
MS Beta-alanine Supplementation	4.6	± 2.0
MS Placebo Group	4.4	± 0.4
HC Beta-alanine Supplementation	5.0	± 1.2
HC Placebo Group	5.1	± 0.9

Lactate peak

Group	Value	95% CI
MS Beta-alanine Supplementation	8.5	± 2.6
MS Placebo Group	9.2	± 1.0
HC Beta-alanine Supplementation	10.6	± 2.6
HC Placebo Group	8.9	± 2.3

Body Composition Primary · 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.

Lean mss

Group	Value	95% CI
MS Beta-alanine Supplementation	51.4	± 7.0
MS Placebo Group	49.2	± 8.4
HC Beta-alanine Supplementation	55.7	± 7.7
HC Placebo Group	50.3	± 10.8

Fat mass

Group	Value	95% CI
MS Beta-alanine Supplementation	16.8	± 9.7
MS Placebo Group	15.5	± 6.6
HC Beta-alanine Supplementation	14.6	± 5.8
HC Placebo Group	16.5	± 5.2

Strength Assessment Core Musculature Primary · 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).

Back

Group	Value	95% CI
MS Beta-alanine Supplementation	257.4	± 66.2
MS Placebo Group	243.3	± 80.3
HC Beta-alanine Supplementation	243.5	± 54.4
HC Placebo Group	256	± 87.7

Abdomen

Group	Value	95% CI
MS Beta-alanine Supplementation	132.7	± 28.9
MS Placebo Group	145.3	± 42.8
HC Beta-alanine Supplementation	141	± 35.9
HC Placebo Group	149.5	± 46.6

Workload Primary · 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).

Group	Value	95% CI
MS Beta-alanine Supplementation	209	± 45
MS Placebo Group	212	± 41
HC Beta-alanine Supplementation	248	± 44
HC Placebo Group	235	± 59

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.