ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients (NUTRALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
Laboratoires NUTRICIA
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Dietary Supplement: Oral nutritional supplementation Not Applicable

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
No Intervention: Control group

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: oral nutritional supplementation

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
Other Names:
  • Fortimel Compact Protein ®
  • Fortimel Crème®




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Combined assessment of Function and Survival (CAFS) [ Time Frame: Mont 3 and month 6 ]
    Combined assessment of Function and Survival (CAFS)

  2. 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:




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥18 years of age, diagnosed with ALS (<2 months before inclusion) according to Airlie House criteria : definite, probable, or probable laboratory supported;
  • Time between first symptoms and diagnosis less than 18 months
  • Sporadic or familial cases
  • Patient agreement to be followed in a given ALS centre during the duration of the study
  • Patients with a loss of at least 1 point in 3 items of the ALSFRS-R rating scale or with a loss of at least 2 points in 2 items of the ALSFRS-R rating scale
  • Patients who signed the informed consent form

Exclusion Criteria:

  • Associated dementia or inability to understand the requirements of the protocol.
  • No helper
  • ONS already begun
  • Artificial nutrition: enteral or parenteral nutrition
  • Known hypersensitivity to components of ONS
  • Absence of treatment with Riluzole (RILUTEK®)
  • Patient under guardianship or curatorship
  • Participation in another research protocol.

Information from the National Library of Medicine

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


Contacts
Contact: Philippe COURATIER, MD 05 55 05 15 69 philippe.couratier@unilim.fr
Contact: Pierre JESUS, MD pierre.jesus@chu-limoges.fr

Locations
France
Service de Neurologie Recruiting
Limoges, France, 87000
Principal Investigator: Philippe COURATIER, MD         
Sub-Investigator: Jean-Claude DESPORT, MD         
Sub-Investigator: Pierre JESUS, MD         
Sponsors and Collaborators
University Hospital, Limoges
Laboratoires NUTRICIA
Investigators
Principal Investigator: Philippe COURATIER, MD CHU Limoges

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02152449     History of Changes
Other Study ID Numbers: I12025
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases