Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| resting energy expenditure (REE) (kcal) | Assessed by indirect calorimetry | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure (mm Hg) | upper arm measurement by certified medical device | one single (baseline) measurement under standardized conditions |
| Body temperature (°C) | measured axillar, by infra-red ear thermometer and non-contact thermoscan |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luzia Valentini, Prof. Dr. | Contact | +49 395 5693 | 2512 | valentini@hs-nb.de |
| Sara Ramminger, M.Sc. | Contact | +49 395 5693 | 1507 | ramminger@hs-nb.de |
| Name | Affiliation | Role |
|---|---|---|
| Luzia Valentini, Prof. Dr. | Neubrandenburg University of Applied Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technical University of Munich | Recruiting | Munich | Bavaria | 80992 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17637089 | Background | Elizabeth Weekes C. Controversies in the determination of energy requirements. Proc Nutr Soc. 2007 Aug;66(3):367-77. doi: 10.1017/S0029665107005630. | |
| 17324655 | Background | 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. doi: 10.1016/j.jada.2007.01.030. No abstract available. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D050177 | Overweight |
| D013851 | Thinness |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| one single (baseline) measurement under standardized conditions |
| Heart rate (bpm) | measured by heart rate band and blood pressure device | one single (baseline) measurement under standardized conditions |
| Body weight (kg) | measured by electronic scale integrated in BIA device | one single (baseline) measurement under standardized conditions |
| Body height (m) | measured by digital stationary stadiometer | one single (baseline) measurement under standardized conditions |
| Fat mass (FM) (kg) | measured by bioelectrical impedance analysis (BIA) | one single (baseline) measurement under standardized conditions |
| Fat-free mass (FFM) (kg) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions |
| Fat-free mass index (FFMI) (kg/m²) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions |
| Fat mass index (FMI) (kg/m²) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions |
| Skeletal muscle mass (SMM) (kg) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions |
| Total body water (TBW) (l) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions |
| Extracellular water (ECW) (l) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions |
| Resistance (R) (Ω) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions |
| Reactance (Xc) (Ω) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions |
| Phase angle (°) | measured by bioelectrical impedance Analysis (BIA) | one single (baseline) measurement under standardized conditions |
| Waist circumference (cm) | measured by measuring tape | one single (baseline) measurement under standardized conditions |
| International Physical Activity Questionnaire (IPAQ) short form | one single (baseline) interview |
| Fulda University of Applied Sciences | Recruiting | Fulda | Hesse | 36030 | Germany |
|
| Dietrich Bonheoffer Hospital of Neubrandenburg | Recruiting | Neubrandenburg | Mecklenburg-Vorpommern | 17033 | Germany |
|
| University of Applied Sciences Neubrandenburg | Recruiting | Neubrandenburg | Mecklenburg-Vorpommern | 17033 | Germany |
|
| Profil Institut for Metabolic Research | Recruiting | Mainz | Rhineland-Palatinate | 55116 | Germany |
|
| Leipzig University - Medical Center IFB AdiposityDiseases | Recruiting | Leipzig | Saxony | 04103 | Germany |
|
| 22704700 | Background | 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. |
| 3074920 | Background | 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. |
| 9843543 | Background | 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. doi: 10.1152/jappl.1998.85.6.2196. |
| 12120418 | Background | Muller 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. doi: 10.1046/j.1467-789x.2002.00057.x. |
| 21266697 | Background | 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. |
| 25184816 | Background | 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. |
| 23218813 | Background | 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. |
| 16277790 | Background | Bader N, Bosy-Westphal A, Dilba B, Muller 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. doi: 10.1079/bjn20051551. |
| 12840206 | Background | Bosy-Westphal A, Eichhorn C, Kutzner D, Illner K, Heller M, Muller 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. doi: 10.1093/jn/133.7.2356. |
| 23643826 | Background | 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. |
| 25076940 | Background | 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. No abstract available. |
| 12900694 | Background | Craig CL, Marshall AL, Sjostrom 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. doi: 10.1249/01.MSS.0000078924.61453.FB. |
| 15357531 | Background | Rutten A, Abu-Omar K. Prevalence of physical activity in the European Union. Soz Praventivmed. 2004;49(4):281-9. doi: 10.1007/s00038-004-3100-4. |
| 23299866 | Background | Bosy-Westphal A, Schautz B, Later W, Kehayias JJ, Gallagher D, Muller 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. |
| D009750 | Nutritional and Metabolic Diseases |