Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients (NUTRALS)
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|ClinicalTrials.gov Identifier: NCT02152449|
Recruitment Status : Unknown
Verified March 2015 by University Hospital, Limoges.
Recruitment status was: Recruiting
First Posted : June 2, 2014
Last Update Posted : March 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis (ALS)||Dietary Supplement: Oral nutritional supplementation||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||310 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact on Functional Status of Early Oral Nutritional Supplementation (ONS) in Amyotrophic Lateral Sclerosis (ALS) Patients|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2017|
No Intervention: Control group
Control group: systematic advice on swallowing, plus:
Experimental: oral nutritional supplementation
Experimental "ONS" Group: systematic advice on swallowing + systematic advice on a fat- and protein-enriched diet, plus:
Dietary Supplement: Oral nutritional supplementation
- Change in the ALSFRS-R slope between T0 and T0+6 months [ Time Frame: Month 6 ]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).
- Combined assessment of Function and Survival (CAFS) [ Time Frame: Mont 3 and month 6 ]Combined assessment of Function and Survival (CAFS)
- Body Mass Index and of Fat Mass. [ Time Frame: Day 1, month 3, months 6: ]
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:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152449
|Contact: Philippe COURATIER, MD||05 55 05 15 firstname.lastname@example.org|
|Contact: Pierre JESUS, MDemail@example.com|
|Service de Neurologie||Recruiting|
|Limoges, France, 87000|
|Principal Investigator: Philippe COURATIER, MD|
|Sub-Investigator: Jean-Claude DESPORT, MD|
|Sub-Investigator: Pierre JESUS, MD|
|Principal Investigator:||Philippe COURATIER, MD||CHU Limoges|