An interventional study of Oral nutritional supplementation in Amyotrophic Lateral Sclerosis (ALS), sponsored by University Hospital, Limoges. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-19.
Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether an early oral nutritional supplementation (ONS) in amyotrophic lateral sclerosis (ALS) patients is effective on the treatment of this rapidly progressive disease.
Amyotrophic lateral sclerosis (ALS) is a rare neurodegenerative disease with a median age at time of diagnosis of 65 years. In France, the incidence ranges between 1.5 and 2.5/100 000 person-year of follow-up. The disease is related to progressive degeneration of motor neurons in the two voluntary motor pathways. It is a very debilitating disease, particularly in terms of autonomy and respiratory function. Its prognosis is poor, with constant worsening during the follow-up, leading to death with a median survival of 24 months after diagnosis. ALS patients are at risk of malnutrition in the short and medium term, because of several factors limiting or stopping food intake, such as functional disability, and swallowing or breathing disorders. The disease is also accompanied in 50-60% of cases by an abnormal increase in energy expenditure (hypermetabolism), causing added weight loss. Previous studies have shown that malnutrition is an independent negative prognostic factor for survival. Besides, at time of diagnosis, 36% of patients have already lost more than 5% of their usual weight. Such a weight loss has been shown to be associated with a 2 fold increased risk of dying, after adjustment for other known prognostic factors. Moreover, patients with a higher fat body mass during the course of the disease have a significant increased survival; and higher levels of serum cholesterol and/or triglycerides are favourable factors for survival. The recommendations for the management of ALS patients, published by French and International groups of experts, have suggested the use of oral nutritional supplementation if food intake does not cover the patient's requirements.
We propose that Oral Nutritional Supplementation (ONS) should be used (i) systematically and (ii) earlier (as early as the time of diagnosis) in order to enable patients to maintain proper nutritional status.
Such an intervention could delay the progression of the disease if the metabolic disorders in ALS are not solely the result of progression of the disease, but are implicated in its course and outcome.
This is a parallel randomized study aimed To assess the benefits of early oral nutritional supplementation (ONS) on neurological functional status evaluated by the slope of the revised ALS Functional rating Scale (ALSFRS-R) between inclusion (T0) and T0+6 months in newly diagnosed ALS pati
1,000 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 284 are open to participants now.
This study's enrollment of 229 is above the median of 37 across 678 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →University Hospital, Limoges is the lead sponsor of 262 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Control group: systematic advice on swallowing, plus: * If no weight loss compared to usual weight: no intervention * if weight loss \<5%: advice on a fat- and protein-enriched diet * if weight loss ≥5%: advice on a fat- and protein-enriched diet + 1 unit of ONS/day per os
Experimental "ONS" Group: systematic advice on swallowing + systematic advice on a fat- and protein-enriched diet, plus: * if no weight loss compared to usual weight: 1 ONS/day per os * if weight loss \<5% compared to usual weight: 2 ONS/day per os * if weight loss ≥5% compared to usual weight: 3 ONS/day per os
Dietary Supplement: Oral nutritional supplementation
Also known as: Fortimel Compact Protein ®, Fortimel Crème®
Change in the ALSFRS-R slope between T0 and T0+6 months
Change in the ALSFRS-R slope between T0 and T0+6 months (ALSFRS-R will be assessed by an examiner blinded to the intervention group).
Time frame: Month 6
Combined assessment of Function and Survival (CAFS)
Combined assessment of Function and Survival (CAFS)
Time frame: Mont 3 and month 6
Body Mass Index and of Fat Mass.
Nutritional status will be evaluated by means of Body Mass Index and of Fat Mass. Measurement will be performed at T0, T0+3 months and T0+6 months:
Time frame: Day 1, month 3, months 6:
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amyotrophic Lateral Sclerosis →
University Hospital, Limoges →