Clinical trial NCT02682537: IC-BASAROTs: New Practice Method for More Accurate Bed-side Assessment of Individual Energy Expenditure
Official title: IC-BASAROTs: Verification of a New Practice Method for More Accurate Bed-side Assessment of Individual Energy Expenditure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Body Weight
Overweight
Thinness
Keywords: Resting energy expenditure
Calorie requirements
Indirect Calorimetry
Lead sponsor: University of Applied Sciences Neubrandenburg
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minimum sample size of n = 1400: 700 mostly healthy people (50% women, aged 18-100 years, BMI 16.5 to 39.9 kg / m²), 420 underweight individuals (50% women, 18 years to 100 years, BMI from 14.0 to 16.4 kg/m²), 280 morbidly obese (50% women,18 years to 100 years, BMI 40.0-49,9 kg/m²).

Recruitment of volunteers is performed in the local trial centers.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: resting energy expenditure (REE) (kcal)
timeFrame: 15 minutes
Secondary outcomes:
measure: blood pressure (mm Hg)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Body temperature (°C)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Heart rate (bpm)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Body weight (kg)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Body height (m)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Fat mass (FM) (kg)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Fat-free mass (FFM) (kg)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Fat-free mass index (FFMI) (kg/m²)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Fat mass index (FMI) (kg/m²)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Skeletal muscle mass (SMM) (kg)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Total body water (TBW) (l)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Extracellular water (ECW) (l)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Resistance (R) (Ω)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Reactance (Xc) (Ω)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Phase angle (°)
timeFrame: one single (baseline) measurement under standardized conditions
measure: Waist circumference (cm)
timeFrame: one single (baseline) measurement under standardized conditions
measure: International Physical Activity Questionnaire (IPAQ) short form
timeFrame: one single (baseline) interview
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technical University of Munich
state: Bavaria
city: Fulda
country: Germany
facility: Fulda University of Applied Sciences
state: Hesse
city: Neubrandenburg
country: Germany
facility: Dietrich Bonheoffer Hospital of Neubrandenburg
state: Mecklenburg-Western Pomerania
city: Neubrandenburg
country: Germany
facility: University of Applied Sciences Neubrandenburg
state: Mecklenburg-Western Pomerania
city: Mainz
country: Germany
facility: Profil Institut for Metabolic Research
state: Rhineland-Palatinate
city: Leipzig
country: Germany
facility: Leipzig University - Medical Center IFB AdiposityDiseases
state: Saxony
Study officials:
affiliation: Neubrandenburg University of Applied Sciences
name: Luzia Valentini, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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