Hypermetabolism in ALS Using Six REE Formulas

Increased Resting Energy Expenditure Compared to Six Predictive Theoretical Equations in Amyotrophic Lateral Sclerosis: a Study Versus Controls

Introduction: About 50-60% of Amyotrophic Lateral Sclerosis (ALS) is characterized by hypermetabolism, defined as 10% or more excess resting energy expenditure (REE) compared to theoretical values. Harris and Benedict's (HB) formula is the equation mainly used to predict REE, but others are also applied in current practice. The present study aimed to assess REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.

Nutritional assessments were performed in ALS patients and in two control populations without hypermetabolism: healthy elderly people (control 1) and patients with non-restrictive-eating disorders (control 2). Weight, height and body composition (by bioimpedance analysis) were assessed.

EE was measured (mREE) by indirect calorimetry and calculated (cREE) using HB 1919 and 1984, World Schofield, De Lorenzo, Johnstone and Mifflin formulas. Mann-Whitney and Chi2 tests were used to compare the equations.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Other: Assesment of REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.

• Study Type: Observational
• Enrollment (Actual): 449

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87 042

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ALS patients

Description

Inclusion Criteria:

• ALS patients
• 18 years old or more
• IC and nutritional assessment within 1.5 months
• delay between diagnosis and IC < 12 months

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ALS	Other: Assesment of REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.
control 1
control 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of REE	EE was measured (mREE) by indirect calorimetry and calculated (cREE) using Harris and Benedict's (HB) formula	indirect calorimetry (IC) and nutritional assessment within 1.5 months, and diagnosis and IC within 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 1996
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Resting energy expenditure; Amyotrophic lateral sclerosis,; Predictive equation
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: mREE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No