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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02682537
Enrollment
1400
Registered
2016-02-15
Start date
2015-03-31
Completion date
2020-12-31
Last updated
2018-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight, Healthy, Overweight, Thinness

Keywords

Resting energy expenditure, Calorie requirements, Indirect Calorimetry

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).

Interventions

None listed

Sponsors

University of Applied Sciences Neubrandenburg
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
resting energy expenditure (REE) (kcal)15 minutesAssessed by indirect calorimetry

Secondary

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

Countries

Germany

Contacts

Primary ContactLuzia Valentini, Prof. Dr.
valentini@hs-nb.de+49 395 5693
Backup ContactSara Ramminger, M.Sc.
ramminger@hs-nb.de+49 395 5693

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026