Hypermetabolism in ALS Using Six REE Formulas

Completed

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

• Registration Number: NCT03382392
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2017-12
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-21
• Last Update Submitted: 2017-12-21
• Study First Posted: 2017-12-22
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ALS	Assesment of REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.	-

Primary Outcome Measures

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