Healthy Clinical Trial
Official title:
IC-BASAROTs: Verification of a New Practice Method for More Accurate Bed-side Assessment of Individual Energy Expenditure
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.
Status | Recruiting |
Enrollment | 1400 |
Est. completion date | December 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Germany | Fulda University of Applied Sciences | Fulda | Hesse |
Germany | Leipzig University - Medical Center IFB AdiposityDiseases | Leipzig | Saxony |
Germany | Profil Institut for Metabolic Research | Mainz | Rhineland-Palatinate |
Germany | Technical University of Munich | Munich | Bavaria |
Germany | Dietrich Bonheoffer Hospital of Neubrandenburg | Neubrandenburg | Mecklenburg-Western Pomerania |
Germany | University of Applied Sciences Neubrandenburg | Neubrandenburg | Mecklenburg-Western Pomerania |
Lead Sponsor | Collaborator |
---|---|
University of Applied Sciences Neubrandenburg |
Germany,
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Müller MJ, Bosy-Westphal A, Kutzner D, Heller M. Metabolically active components of fat-free mass and resting energy expenditure in humans: recent lessons from imaging technologies. Obes Rev. 2002 May;3(2):113-22. Review. — View Citation
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Valentini L, Roth E, Jadrna K, Postrach E, Schulzke JD. The BASA-ROT table: an arithmetic-hypothetical concept for easy BMI-, age-, and sex-adjusted bedside estimation of energy expenditure. Nutrition. 2012 Jul;28(7-8):773-8. doi: 10.1016/j.nut.2011.11.020. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | resting energy expenditure (REE) (kcal) | Assessed by indirect calorimetry | 15 minutes | |
Secondary | blood pressure (mm Hg) | upper arm measurement by certified medical device | one single (baseline) measurement under standardized conditions | |
Secondary | Body temperature (°C) | measured axillar, by infra-red ear thermometer and non-contact thermoscan | one single (baseline) measurement under standardized conditions | |
Secondary | Heart rate (bpm) | measured by heart rate band and blood pressure device | one single (baseline) measurement under standardized conditions | |
Secondary | Body weight (kg) | measured by electronic scale integrated in BIA device | one single (baseline) measurement under standardized conditions | |
Secondary | Body height (m) | measured by digital stationary stadiometer | one single (baseline) measurement under standardized conditions | |
Secondary | Fat mass (FM) (kg) | measured by bioelectrical impedance analysis (BIA) | one single (baseline) measurement under standardized conditions | |
Secondary | Fat-free mass (FFM) (kg) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions | |
Secondary | Fat-free mass index (FFMI) (kg/m²) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions | |
Secondary | Fat mass index (FMI) (kg/m²) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions | |
Secondary | Skeletal muscle mass (SMM) (kg) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions | |
Secondary | Total body water (TBW) (l) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions | |
Secondary | Extracellular water (ECW) (l) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions | |
Secondary | Resistance (R) (O) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions | |
Secondary | Reactance (Xc) (O) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions | |
Secondary | Phase angle (°) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions | |
Secondary | Waist circumference (cm) | measured by measuring tape | one single (baseline) measurement under standardized conditions | |
Secondary | International Physical Activity Questionnaire (IPAQ) short form | one single (baseline) interview |
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