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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02682537
• Other study ID #: BB023/15
• Status: Recruiting
• First received: February 8, 2016
• Last updated: April 9, 2018
• Start date: March 2015
• Est. completion date: December 2020

Study information

• Verified date: April 2018
• Source: University of Applied Sciences Neubrandenburg
• Contact: Luzia Valentini, Prof. Dr.
• Phone: +49 395 5693
• Email: valentini[@]hs-nb.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Body Weight
• Healthy
• Overweight
• Thinness

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Applied Sciences Neubrandenburg

Country where clinical trial is conducted

Germany, 

References & Publications (16)

Bader N, Bosy-Westphal A, Dilba B, Müller MJ. Intra- and interindividual variability of resting energy expenditure in healthy male subjects -- biological and methodological variability of resting energy expenditure. Br J Nutr. 2005 Nov;94(5):843-9. — View Citation

Berger MM, Pichard C. Development and current use of parenteral nutrition in critical care - an opinion paper. Crit Care. 2014 Aug 8;18(4):478. doi: 10.1186/s13054-014-0478-0. Review. — View Citation

Bosy-Westphal A, Eichhorn C, Kutzner D, Illner K, Heller M, Müller MJ. The age-related decline in resting energy expenditure in humans is due to the loss of fat-free mass and to alterations in its metabolically active components. J Nutr. 2003 Jul;133(7):2356-62. — View Citation

Bosy-Westphal A, Schautz B, Later W, Kehayias JJ, Gallagher D, Müller MJ. What makes a BIA equation unique? Validity of eight-electrode multifrequency BIA to estimate body composition in a healthy adult population. Eur J Clin Nutr. 2013 Jan;67 Suppl 1:S14-21. doi: 10.1038/ejcn.2012.160. — View Citation

Chaput JP, St-Onge MP. Increased food intake by insufficient sleep in humans: are we jumping the gun on the hormonal explanation? Front Endocrinol (Lausanne). 2014 Jul 15;5:116. doi: 10.3389/fendo.2014.00116. eCollection 2014. Review. — View Citation

Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. — View Citation

Dickerson RN. Optimal caloric intake for critically ill patients: first, do no harm. Nutr Clin Pract. 2011 Feb;26(1):48-54. doi: 10.1177/0884533610393254. Review. — View Citation

Elizabeth Weekes C. Controversies in the determination of energy requirements. Proc Nutr Soc. 2007 Aug;66(3):367-77. Review. — View Citation

Gonnissen HK, Adam TC, Hursel R, Rutters F, Verhoef SP, Westerterp-Plantenga MS. Sleep duration, sleep quality and body weight: parallel developments. Physiol Behav. 2013 Sep 10;121:112-6. doi: 10.1016/j.physbeh.2013.04.007. Epub 2013 May 3. Review. — View Citation

Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3. — View Citation

Lawrence M. Predicting energy requirements: is energy expenditure proportional to the BMR or to body weight? An analysis of data collected in rural Gambian women. Eur J Clin Nutr. 1988 Nov;42(11):919-27. Review. — View Citation

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

Piers LS, Soares MJ, McCormack LM, O'Dea K. Is there evidence for an age-related reduction in metabolic rate? J Appl Physiol (1985). 1998 Dec;85(6):2196-204. — View Citation

Rütten A, Abu-Omar K. Prevalence of physical activity in the European Union. Soz Praventivmed. 2004;49(4):281-9. — View Citation

Schoeller DA. Making indirect calorimetry a gold standard for predicting energy requirements for institutionalized patients. J Am Diet Assoc. 2007 Mar;107(3):390-2. — View Citation

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

Outcome

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