Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients

NCT02152449 | Completed

• 1 other identifier: I12025
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Combined assessment of Function and Survival (CAFS)

  Mont 3 and month 6

• Body Mass Index and of Fat Mass.

  Day 1, month 3, months 6:

Study Arms (2)

Control group

NO INTERVENTION

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

oral nutritional supplementation

EXPERIMENTAL

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

Interventions

Oral nutritional supplementation DIETARY_SUPPLEMENT

Also known as: Fortimel Compact Protein ®, Fortimel Crème®

oral nutritional supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead
• Laboratoires NUTRICIA: collaborator

Study Sites (1)

Service de Neurologie

Limoges, 87000, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Philippe COURATIER, MD

  CHU Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: June 1, 2021
• Last Updated: August 19, 2021

Record last verified: 2019-07

Locations

FR (1)