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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Healthy, Body Weight, Overweight, Thinness

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female, BMI: 14,00-16,49 kg/m²<br>Age: 18 - 100 Years | |
| Female, BMI: 16,50-18,49 kg/m²<br>Age: 18 - 100 years | |
| Female, BMI: 18,50-19,99 kg/m²<br>Age: 18 - 100 years | |
| Female, BMI: 20,00-24,99 kg/m²<br>Age: 18 - 100 years | |
| Female, BMI: 25,00-29,99 kg/m²<br>Age: 18 - 100 years | |
| Female, BMI: 30,00-34,99 kg/m²<br>Age: 18 - 100 years | |
| Female, BMI: 35,00-39,99 kg/m²<br>Age: 18 - 100 years | |
| Female, BMI: 40,00-44,99 kg/m²<br>Age: 18 - 100 years | |
| Female, BMI: 45,00-49,99 kg/m²<br>Age: 18 - 100 years | |
| Male, BMI: 14,00-16,49 kg/m²<br>Age: 18 - 100 years | |
| Male, BMI: 16,50-18,49 kg/m²<br>Age: 18 - 100 years | |
| Male, BMI: 18,50-19,99 kg/m²<br>Age: 18 - 100 years | |
| Male, BMI: 20,00-24,99 kg/m²<br>Age: 18 - 100 years | |
| Male, BMI: 25,00-29,99 kg/m²<br>Age: 18 - 100 years | |
| Male, BMI: 30,00-34,99 kg/m²<br>Age: 18 - 100 years | |
| Male, BMI: 35,00-39,99 kg/m²<br>Age: 18 - 100 years | |
| Male, BMI: 40,00-44,99 kg/m²<br>Age: 18 - 100 years | |
| Male, BMI: 45,00-49,99 kg/m²<br>Age: 18 - 100 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting energy expenditure (REE) (kcal) | Assessed by indirect calorimetry | 15 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resting energy expenditure, Calorie requirements, Indirect Calorimetry