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

U

University of Applied Sciences Neubrandenburg

Status

Unknown

Conditions

Overweight
Healthy
Thinness
Body Weight

Study type

Observational

Funder types

Other

Identifiers

NCT02682537
BB023/15

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,400 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

1,400 participants in 18 patient groups

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

Trial contacts and locations

6

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Central trial contact

Sara Ramminger, M.Sc.; Luzia Valentini, Prof. Dr.

Data sourced from clinicaltrials.gov

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