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

August 18, 2021 updated by: University Hospital, Limoges

Impact on Functional Status of Early Oral Nutritional Supplementation (ONS) in Amyotrophic Lateral Sclerosis (ALS) Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

229

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87000
        • Service de Neurologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined assessment of Function and Survival (CAFS)
Time Frame: Mont 3 and month 6
Combined assessment of Function and Survival (CAFS)
Mont 3 and month 6
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:
Day 1, month 3, months 6:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Collaborators

Laboratoires NUTRICIA

Investigators

  • Principal Investigator: Philippe COURATIER, MD, CHU Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I12025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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