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

NCT02682537 | Unknown

• 1 other identifier: BB023/15
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 6

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.

Conditions

Healthy; Body Weight; Overweight; Thinness

Keywords

Resting energy expenditure; Calorie requirements; Indirect Calorimetry

Outcome Measures

Primary Outcomes (1)

• resting energy expenditure (REE) (kcal)

  Assessed by indirect calorimetry

  15 minutes

Secondary Outcomes (17)

• blood pressure (mm Hg)

  one single (baseline) measurement under standardized conditions

• Body temperature (°C)

  one single (baseline) measurement under standardized conditions

• Heart rate (bpm)

  one single (baseline) measurement under standardized conditions

• Body weight (kg)

  one single (baseline) measurement under standardized conditions

• Body height (m)

  one single (baseline) measurement under standardized conditions

Study Arms (18)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• female, male
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Applied Sciences Neubrandenburg: lead

Study Sites (6)

Technical University of Munich

Munich, Bavaria, 80992, Germany

RECRUITING

Fulda University of Applied Sciences

Fulda, Hesse, 36030, Germany

RECRUITING

Dietrich Bonheoffer Hospital of Neubrandenburg

Neubrandenburg, Mecklenburg-Vorpommern, 17033, Germany

RECRUITING

University of Applied Sciences Neubrandenburg

Neubrandenburg, Mecklenburg-Vorpommern, 17033, Germany

RECRUITING

Profil Institut for Metabolic Research

Mainz, Rhineland-Palatinate, 55116, Germany

RECRUITING

Leipzig University - Medical Center IFB AdiposityDiseases

Leipzig, Saxony, 04103, Germany

RECRUITING

Related Publications (16)

• Elizabeth Weekes C. Controversies in the determination of energy requirements. Proc Nutr Soc. 2007 Aug;66(3):367-77. doi: 10.1017/S0029665107005630.

  PMID: 17637089 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.

  PMID: 17324655 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.

  PMID: 22704700 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.

  PMID: 3074920 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.

  PMID: 9843543 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.

  PMID: 12120418 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.

  PMID: 21266697 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.

  PMID: 25184816 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.

  PMID: 23218813 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.

  PMID: 16277790 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.

  PMID: 12840206 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.

  PMID: 23643826 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.

  PMID: 25076940 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.

  PMID: 12900694 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.

  PMID: 15357531 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.

  PMID: 23299866 BACKGROUND

MeSH Terms

Conditions

Body Weight; Overweight; Thinness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Luzia Valentini, Prof. Dr.

  Neubrandenburg University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luzia Valentini, Prof. Dr.

CONTACT

+49 395 5693; valentini@hs-nb.de

Sara Ramminger, M.Sc.

CONTACT

+49 395 5693; ramminger@hs-nb.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 15, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (6)