Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

— NUTRALS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152449
• Other study ID #: I12025
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: June 2021

Study information

• Verified date: July 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: June 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Dietary Supplement:
• Oral nutritional supplementation

Locations

Country	Name	City	State
France	Service de Neurologie	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Laboratoires NUTRICIA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Month 6
Secondary	Combined assessment of Function and Survival (CAFS)	Combined assessment of Function and Survival (CAFS)	Mont 3 and month 6
Secondary	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:	Day 1, month 3, months 6: