Skip to main content
OpenTrials
Completed

NCT Number: NCT03378375

Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis, Creation of a ALS-specific Equation

Introduction: Resting energy expenditure (REE) formulas for healthy people (HP) are used to calculate REE (cREE) in amyotrophic lateral sclerosis (ALS) patients. In ALS an increase of measured REE (mREE) in indirect calometry (IC) compared to cREE is found in 50-60%. The aims were (i) to assess accuracy of cREE assessed using eleven formulas as compared to mREE and (ii) to create if needed a specific cREE formula for ALS patients.

Method: ALS patients followed in the ALS expert center of Limoges between 1996 and 2014 and with a nutritional evaluation were included. mREE assessed with IC and cREE calculated with eleven predictive formulas (Harris Benedict (HB) 1919, HB 1984, WSchofield, De Lorenzo, Johnstone, Mifflin, WHO/FAO, Owen, Fleisch, Wang and Rosenbaum) were collected at time of diagnosis. Fat free mass (FFM) and fat mass (FM) were measured with impedancemetry. A Bland and Altman analysis was carried out. The percentage of accurate prediction ± 10%of mREE, and intraclass correlation coefficients (ICC) were calculated. Using a derivation sample, a new REE formula was created using multiple linear regression according to sex, age, FFM and FM. Accuracy of this formula was assessed in a validation sample.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ALS diagnosed patients according to Airlie House criteria
  • treated with riluzole
  • respiratory quotient (RQ) of patients in indirect calorimetry (IC) should be in between 0.7 and 0.87

Exclusion criteria

-

Treatment and study plan

nutritional assessement

Other

Primary outcomes

  1. Resting energy expenditure emeasures

    Time frame: nutritional assessement should have been be performed within a 1.5 months' time period. IC had to be performed no later than 12 months after diagnosis.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Important dates

Study start
1996
Primary completion
2014
Study completion
2014
First posted
Dec 19, 2017
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.