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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682537
Recruitment Status : 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

Tracking Information
First Submitted Date February 8, 2016
First Posted Date February 15, 2016
Last Update Posted Date April 11, 2018
Study Start Date March 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2016)
resting energy expenditure (REE) (kcal) [ Time Frame: 15 minutes ]
Assessed by indirect calorimetry
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 12, 2016)
  • blood pressure (mm Hg) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    upper arm measurement by certified medical device
  • Body temperature (°C) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured axillar, by infra-red ear thermometer and non-contact thermoscan
  • Heart rate (bpm) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by heart rate band and blood pressure device
  • Body weight (kg) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by electronic scale integrated in BIA device
  • Body height (m) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by digital stationary stadiometer
  • Fat mass (FM) (kg) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance analysis (BIA)
  • Fat-free mass (FFM) (kg) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)
  • Fat-free mass index (FFMI) (kg/m²) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)
  • Fat mass index (FMI) (kg/m²) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)
  • Skeletal muscle mass (SMM) (kg) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)
  • Total body water (TBW) (l) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)
  • Extracellular water (ECW) (l) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)
  • Resistance (R) (Ω) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)
  • Reactance (Xc) (Ω) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)
  • Phase angle (°) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by bioelectrical impedance Analysis (BIA)
  • Waist circumference (cm) [ Time Frame: one single (baseline) measurement under standardized conditions ]
    measured by measuring tape
  • International Physical Activity Questionnaire (IPAQ) short form [ Time Frame: one single (baseline) interview ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Healthy
  • Body Weight
  • Overweight
  • Thinness
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 12, 2016)
1400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
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
Listed Location Countries Germany
Removed Location Countries Austria,   Switzerland
 
Administrative Information
NCT Number NCT02682537
Other Study ID Numbers BB023/15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Luzia Valentini, University of Applied Sciences Neubrandenburg
Study Sponsor University of Applied Sciences Neubrandenburg
Collaborators Not Provided
Investigators
Principal Investigator: Luzia Valentini, Prof. Dr. Neubrandenburg University of Applied Sciences
PRS Account University of Applied Sciences Neubrandenburg
Verification Date April 2018