IC-BASAROTs: New Practice Method for More Accurate Bed-side Assessment of Individual Energy Expenditure

• Conditions: Thinness; Healthy; Body Weight; Overweight

• Registration Number: NCT02682537
• Lead Sponsor: University of Applied Sciences Neubrandenburg

Brief Summary

Assessment of resting energy expenditure (REE) by indirect calorimetry (IC) in 1400 healthy individuals for arithmetical transformation into an bedside tool to estimate energy requirements in dietary practice (BASAROTs). A multinational, multicenter, prospective cross-sectional study.

Detailed Description

The assessment of energy expenditure is the basic requirement for any nutritional therapy. Nevertheless, there is still no accurate, scientifically validated and practical bedside tool.

The reference method for energy expenditure measurement is indirect calorimetry (IC). High costs, time requirements and the need for trained personal are main reasons for its limited use in clinical practice. Also arithmetical calculations, such as the Harris-Benedict equation, are not widely accepted.

In general energy expenditure is often estimated by so called rules of thumbs, a method requiring only one multiplication with body weight (for example: 25 kcal/kg body weight). Sex, age and BMI are usually not considered, although they are independent predictors of energy expenditure. Thus, energy expenditure estimations are often inaccurate, especially in older and overweight/obese persons.

Therefore, it is important to develop a bedside tool that is more accurate but simple enough to be accepted by practitioners. In 2004, the Austrian Society of Clinical Nutrition published the first BMI, aged and sex adapted rule of thumbs, called BASAROTs (BMI Age Sex Adjusted Rule Of Thumbs). Those were, however, based on results of the Harris Benedict equation.

The main objective of the present study is, therefore, to replace the existing BASAROTs by BASAROTs based on actual measurements of resting energy expenditure by indirect calorimetry (IC-BASAROTs).

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-15
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-11
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• female, male
• 18 years to 85 years
• Body Mass Index: 14,0 - 49,9 kg/m²
• Eastern Cooperative Oncology Group (ECOG) Performance Status (Grade 0 or 1)
• normal thyroid function
• subjective health in dependence of BMI (underweight, normal weight, obesity, morbid obesity)

Exclusion Criteria

• implanted pacemaker
• amputations
• paresis (mono- and diparesis)
• Asian or African descent
• above-average physical activity (competitive sport)
• present or suspicion of malignant neoplasms (tumors, metastases, hemato-oncological diseases)
• severe diseases (organ diseases, neurological diseases)
• severe dementia (MMSE < 20 points)
• pregnancy
• participation in other trials
• subjects with expect non-compliance to protocol guidelines
• intake of:
• lithium compound
• neuroleptics: Olanzapine (Zyprexa ®), Clozapine, Sertindole, Ziprasidone, Haloperidol, Thioridazine
• anticonvulsant (Carbamazepin, Valproic Acid, Topiramate)
• noradrenalin-reuptake-inhibitor (NARI): Reboxetine , Atomoxetine
• tricyclic antidepressants (Amitryptiline, Clomipramine, Doxepin, Imipramine, Trimipramin)
• Lorcaserin
• interferon-alfa, interferon-beta
• Baclofen
• Orciprenaline
• Amiodarona
• Insulin
• corticoid therapy (oral)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
resting energy expenditure (REE) (kcal)	15 minutes	Assessed by indirect calorimetry

Secondary Outcome Measures

Name	Time	Method
Extracellular water (ECW) (l)	one single (baseline) measurement under standardized conditions	measured by bioelectrical impedance Analysis (BIA)
Skeletal muscle mass (SMM) (kg)	one single (baseline) measurement under standardized conditions	measured by bioelectrical impedance Analysis (BIA)
Total body water (TBW) (l)	one single (baseline) measurement under standardized conditions	measured by bioelectrical impedance Analysis (BIA)
blood pressure (mm Hg)	one single (baseline) measurement under standardized conditions	upper arm measurement by certified medical device
Body temperature (°C)	one single (baseline) measurement under standardized conditions	measured axillar, by infra-red ear thermometer and non-contact thermoscan
Heart rate (bpm)	one single (baseline) measurement under standardized conditions	measured by heart rate band and blood pressure device
Resistance (R) (Ω)	one single (baseline) measurement under standardized conditions	measured by bioelectrical impedance Analysis (BIA)
Body weight (kg)	one single (baseline) measurement under standardized conditions	measured by electronic scale integrated in BIA device
Fat mass (FM) (kg)	one single (baseline) measurement under standardized conditions	measured by bioelectrical impedance analysis (BIA)
Fat-free mass (FFM) (kg)	one single (baseline) measurement under standardized conditions	measured by bioelectrical impedance Analysis (BIA)
Body height (m)	one single (baseline) measurement under standardized conditions	measured by digital stationary stadiometer
Fat-free mass index (FFMI) (kg/m²)	one single (baseline) measurement under standardized conditions	measured by bioelectrical impedance Analysis (BIA)
Fat mass index (FMI) (kg/m²)	one single (baseline) measurement under standardized conditions	measured by bioelectrical impedance Analysis (BIA)
Phase angle (°)	one single (baseline) measurement under standardized conditions	measured by bioelectrical impedance Analysis (BIA)
Waist circumference (cm)	one single (baseline) measurement under standardized conditions	measured by measuring tape
Reactance (Xc) (Ω)	one single (baseline) measurement under standardized conditions	measured by bioelectrical impedance Analysis (BIA)
International Physical Activity Questionnaire (IPAQ) short form	one single (baseline) interview

Trial Locations

Locations (6)

Technical University of Munich; 🇩🇪 Munich, Bavaria, Germany

Fulda University of Applied Sciences; 🇩🇪 Fulda, Hesse, Germany

Dietrich Bonheoffer Hospital of Neubrandenburg; 🇩🇪 Neubrandenburg, Mecklenburg-Western Pomerania, Germany

University of Applied Sciences Neubrandenburg; 🇩🇪 Neubrandenburg, Mecklenburg-Western Pomerania, Germany

Profil Institut for Metabolic Research; 🇩🇪 Mainz, Rhineland-Palatinate, Germany

Leipzig University - Medical Center IFB AdiposityDiseases; 🇩🇪 Leipzig, Saxony, Germany