Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682537
Recruitment Status : Unknown
Verified April 2018 by Luzia Valentini, University of Applied Sciences Neubrandenburg.
Recruitment status was:  Recruiting
First Posted : February 15, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Luzia Valentini, 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.

Condition or disease
Healthy Body Weight Overweight Thinness

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: IC-BASAROTs: Verification of a New Practice Method for More Accurate Bed-side Assessment of Individual Energy Expenditure
Study Start Date : March 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Group/Cohort
Female, BMI: 14,00-16,49 kg/m²
Age: 18 - 100 Years
Female, BMI: 16,50-18,49 kg/m²
Age: 18 - 100 years
Female, BMI: 18,50-19,99 kg/m²
Age: 18 - 100 years
Female, BMI: 20,00-24,99 kg/m²
Age: 18 - 100 years
Female, BMI: 25,00-29,99 kg/m²
Age: 18 - 100 years
Female, BMI: 30,00-34,99 kg/m²
Age: 18 - 100 years
Female, BMI: 35,00-39,99 kg/m²
Age: 18 - 100 years
Female, BMI: 40,00-44,99 kg/m²
Age: 18 - 100 years
Female, BMI: 45,00-49,99 kg/m²
Age: 18 - 100 years
Male, BMI: 14,00-16,49 kg/m²
Age: 18 - 100 years
Male, BMI: 16,50-18,49 kg/m²
Age: 18 - 100 years
Male, BMI: 18,50-19,99 kg/m²
Age: 18 - 100 years
Male, BMI: 20,00-24,99 kg/m²
Age: 18 - 100 years
Male, BMI: 25,00-29,99 kg/m²
Age: 18 - 100 years
Male, BMI: 30,00-34,99 kg/m²
Age: 18 - 100 years
Male, BMI: 35,00-39,99 kg/m²
Age: 18 - 100 years
Male, BMI: 40,00-44,99 kg/m²
Age: 18 - 100 years
Male, BMI: 45,00-49,99 kg/m²
Age: 18 - 100 years



Primary Outcome Measures :
  1. resting energy expenditure (REE) (kcal) [ Time Frame: 15 minutes ]
    Assessed by indirect calorimetry


Secondary Outcome Measures :
  1. blood pressure (mm Hg) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    upper arm measurement by certified medical device

  2. Body temperature (°C) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured axillar, by infra-red ear thermometer and non-contact thermoscan

  3. Heart rate (bpm) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by heart rate band and blood pressure device

  4. Body weight (kg) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by electronic scale integrated in BIA device

  5. Body height (m) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by digital stationary stadiometer

  6. Fat mass (FM) (kg) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance analysis (BIA)

  7. Fat-free mass (FFM) (kg) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)

  8. Fat-free mass index (FFMI) (kg/m²) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)

  9. Fat mass index (FMI) (kg/m²) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)

  10. Skeletal muscle mass (SMM) (kg) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)

  11. Total body water (TBW) (l) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)

  12. Extracellular water (ECW) (l) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)

  13. Resistance (R) (Ω) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)

  14. Reactance (Xc) (Ω) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)

  15. Phase angle (°) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)

  16. Waist circumference (cm) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by measuring tape

  17. International Physical Activity Questionnaire (IPAQ) short form [ Time Frame: one single (baseline) interview ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682537


Contacts
Layout table for location contacts
Contact: Luzia Valentini, Prof. Dr. +49 395 5693 ext 2512 valentini@hs-nb.de
Contact: Sara Ramminger, M.Sc. +49 395 5693 ext 1507 ramminger@hs-nb.de

Locations
Layout table for location information
Germany
Technical University of Munich Recruiting
Munich, Bavaria, Germany, 80992
Contact: Christina Holzapfel, Dr.       christina.holzapfel@tum.de   
Fulda University of Applied Sciences Recruiting
Fulda, Hesse, Germany, 36030
Contact: Kathrin Kohlenberg-Müller, Prof. Dr.    +49 661 9649 378    kathrin.kohlenberg-mueller@he.hs-fulda.de   
Dietrich Bonheoffer Hospital of Neubrandenburg Recruiting
Neubrandenburg, Mecklenburg-Western Pomerania, Germany, 17033
Contact: Peter Keil, Dr. med.    +49 0375 775 3700    keiljp@dbknb.de   
University of Applied Sciences Neubrandenburg Recruiting
Neubrandenburg, Mecklenburg-Western Pomerania, Germany, 17033
Contact: Luzia Valentini, Prof. Dr.    +49 395 5693 2512    valentini@hs-nb.de   
Contact: Sara Ramminger, M. Sc.    +49 395 5693 1507    ramminger@hs-nb.de   
Profil Institut for Metabolic Research Recruiting
Mainz, Rhineland-Palatinate, Germany, 55116
Contact: Leona Plum-Mörschel, Dr       leona.plum-moerschel@profil.com   
Leipzig University - Medical Center IFB AdiposityDiseases Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Tanja Schütz, Dr.    +49 341 97 15 957    tatjana.schuetz@medizin.uni-leipzig.de   
Sponsors and Collaborators
University of Applied Sciences Neubrandenburg
Investigators
Layout table for investigator information
Principal Investigator: Luzia Valentini, Prof. Dr. Neubrandenburg University of Applied Sciences
Publications:

Layout table for additonal information
Responsible Party: Luzia Valentini, Prof. Dr., University of Applied Sciences Neubrandenburg
ClinicalTrials.gov Identifier: NCT02682537    
Other Study ID Numbers: BB023/15
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The other study centers forward us pseudonymised participant data for evaluation. It might also be possible that we share selected pseudonymised participant data with the other study centers.
Keywords provided by Luzia Valentini, University of Applied Sciences Neubrandenburg:
Resting energy expenditure
Calorie requirements
Indirect Calorimetry
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight
Thinness