HealthyNCT02682537
IC-BASAROTs: New Practice Method for More Accurate Bed-side Assessment of Individual Energy Expenditure
An observational study of Healthy and Body Weight, run by University of Applied Sciences Neubrandenburg at 6 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Body Weight, Overweight
- How many people
- 1,400 participants
- Where
- 6 sitesGermany
- Study dates
- Mar 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 24Show fewer
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Fulda University of Applied Sciences
Fulda, Hesse, 36030
Kathrin Kohlenberg-Müller, Prof. Dr., +49 661 9649 378, kathrin.kohlenberg-mueller@he.hs-fulda.de
- Recruiting
Leipzig University - Medical Center IFB AdiposityDiseases
Leipzig, Saxony, 04103
Tanja Schütz, Dr., +49 341 97 15 957, tatjana.schuetz@medizin.uni-leipzig.de
- Recruiting
Profil Institut for Metabolic Research
Mainz, Rhineland-Palatinate, 55116
Leona Plum-Mörschel, Dr, leona.plum-moerschel@profil.com
- Recruiting
Technical University of Munich
Munich, Bavaria, 80992
Christina Holzapfel, Dr., christina.holzapfel@tum.de
- Recruiting
Dietrich Bonheoffer Hospital of Neubrandenburg
Neubrandenburg, Mecklenburg-Vorpommern, 17033
Peter Keil, Dr. med., +49 0375 775 3700, keiljp@dbknb.de
- Recruiting
University of Applied Sciences Neubrandenburg
Neubrandenburg, Mecklenburg-Vorpommern, 17033
Luzia Valentini, Prof. Dr., +49 395 5693 2512, valentini@hs-nb.de
Sara Ramminger, M. Sc., +49 395 5693 1507, ramminger@hs-nb.de
About this study
Official title: IC-BASAROTs: Verification of a New Practice Method for More Accurate Bed-side Assessment of Individual Energy Expenditure
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.
Read the 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).
- Conditions
- Healthy, Body Weight, Overweight, Thinness
- Keywords
- Resting energy expenditure, Calorie requirements, Indirect Calorimetry
- Medical subject headings
- Body Weight, Overweight, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting energy expenditure (REE) (kcal)
Assessed by indirect calorimetry
Measured: 15 minutes
Secondary outcomes (17)
blood pressure (mm Hg)
upper arm measurement by certified medical device
Measured: one single (baseline) measurement under standardized conditions
Body temperature (°C)
measured axillar, by infra-red ear thermometer and non-contact thermoscan
Measured: one single (baseline) measurement under standardized conditions
Heart rate (bpm)
measured by heart rate band and blood pressure device
Measured: one single (baseline) measurement under standardized conditions
Body weight (kg)
measured by electronic scale integrated in BIA device
Measured: one single (baseline) measurement under standardized conditions
Body height (m)
measured by digital stationary stadiometer
Measured: one single (baseline) measurement under standardized conditions
Fat mass (FM) (kg)
measured by bioelectrical impedance analysis (BIA)
Measured: one single (baseline) measurement under standardized conditions
Fat-free mass (FFM) (kg)
measured by bioelectrical impedance Analysis (BIA)
Measured: one single (baseline) measurement under standardized conditions
Fat-free mass index (FFMI) (kg/m²)
measured by bioelectrical impedance Analysis (BIA)
Measured: one single (baseline) measurement under standardized conditions
Fat mass index (FMI) (kg/m²)
measured by bioelectrical impedance Analysis (BIA)
Measured: one single (baseline) measurement under standardized conditions
Skeletal muscle mass (SMM) (kg)
measured by bioelectrical impedance Analysis (BIA)
Measured: one single (baseline) measurement under standardized conditions
Total body water (TBW) (l)
measured by bioelectrical impedance Analysis (BIA)
Measured: one single (baseline) measurement under standardized conditions
Extracellular water (ECW) (l)
measured by bioelectrical impedance Analysis (BIA)
Measured: one single (baseline) measurement under standardized conditions
Resistance (R) (Ω)
measured by bioelectrical impedance Analysis (BIA)
Measured: one single (baseline) measurement under standardized conditions
Reactance (Xc) (Ω)
measured by bioelectrical impedance Analysis (BIA)
Measured: one single (baseline) measurement under standardized conditions
Phase angle (°)
measured by bioelectrical impedance Analysis (BIA)
Measured: one single (baseline) measurement under standardized conditions
Waist circumference (cm)
measured by measuring tape
Measured: one single (baseline) measurement under standardized conditions
International Physical Activity Questionnaire (IPAQ) short form
Measured: one single (baseline) interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences Neubrandenburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luzia Valentini, University of Applied Sciences Neubrandenburg
- Investigators
- Luzia Valentini, Prof. Dr., Principal investigator, Neubrandenburg University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682537
- Sponsor's protocol ID
- BB023/15
- Status last verified
- Apr 2018
- First submitted
- 8 Feb 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
Elizabeth Weekes C. Controversies in the determination of energy requirements. Proc Nutr Soc. 2007 Aug;66(3):367-77. doi: 10.1017/S0029665107005630.
PubMed 17637089Schoeller 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.
PubMed 17324655Valentini 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.
PubMed 22704700Lawrence 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.
PubMed 3074920Piers 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.
PubMed 9843543Muller 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.
PubMed 12120418Dickerson 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.
PubMed 21266697Berger 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.
PubMed 25184816Heidegger 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.
PubMed 23218813Bader 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.
PubMed 16277790Bosy-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.
PubMed 12840206Gonnissen 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.
PubMed 23643826Chaput 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.
PubMed 25076940Craig 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.
PubMed 12900694Rutten 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.
PubMed 15357531
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IC-BASAROTs: Verification of a New Practice Method for More Accurate Bed-side Assessment of Individual Energy Expenditure
- ClinicalTrials.gov ID
- NCT02682537
- Acronym / sponsor ID
- BB023/15
- Conditions
- Healthy, Body Weight, Overweight, Thinness
- Keywords
- Resting energy expenditure, Calorie requirements, Indirect Calorimetry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University of Applied Sciences NeubrandenburgUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- implanted pacemaker
- amputations
- paresis (mono- and diparesis)
- Asian or African descent
- above-average physical activity (competitive sport)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
resting energy expenditure (REE) (kcal)
Time frame: 15 minutes
Assessed by indirect calorimetry
17 secondary outcomes
blood pressure (mm Hg)
Time frame: one single (baseline) measurement under standardized conditions
Body temperature (°C)
Time frame: one single (baseline) measurement under standardized conditions
Heart rate (bpm)
Time frame: one single (baseline) measurement under standardized conditions
Body weight (kg)
Time frame: one single (baseline) measurement under standardized conditions
Body height (m)
Time frame: one single (baseline) measurement under standardized conditions
Fat mass (FM) (kg)
Time frame: one single (baseline) measurement under standardized conditions
Fat-free mass (FFM) (kg)
Time frame: one single (baseline) measurement under standardized conditions
Fat-free mass index (FFMI) (kg/m²)
Time frame: one single (baseline) measurement under standardized conditions
Fat mass index (FMI) (kg/m²)
Time frame: one single (baseline) measurement under standardized conditions
Skeletal muscle mass (SMM) (kg)
Time frame: one single (baseline) measurement under standardized conditions
Total body water (TBW) (l)
Time frame: one single (baseline) measurement under standardized conditions
Extracellular water (ECW) (l)
Time frame: one single (baseline) measurement under standardized conditions
Resistance (R) (Ω)
Time frame: one single (baseline) measurement under standardized conditions
Reactance (Xc) (Ω)
Time frame: one single (baseline) measurement under standardized conditions
Phase angle (°)
Time frame: one single (baseline) measurement under standardized conditions
Waist circumference (cm)
Time frame: one single (baseline) measurement under standardized conditions
International Physical Activity Questionnaire (IPAQ) short form
Time frame: one single (baseline) interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Background: PubMed 17637089Elizabeth Weekes C. Controversies in the determination of energy requirements. Proc Nutr Soc. 2007 Aug;66(3):367-77. doi: 10.1017/S0029665107005630.
- Background: PubMed 17324655Schoeller 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.
- Background: PubMed 22704700Valentini 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.
- Background: PubMed 3074920Lawrence 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.
- Background: PubMed 9843543Piers 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.
- Background: PubMed 12120418Muller 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.
- Background: PubMed 21266697Dickerson 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.
- Background: PubMed 25184816Berger 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.
- Background: PubMed 23218813Heidegger 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.
- Background: PubMed 16277790Bader 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.
- Background: PubMed 12840206Bosy-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.
- Background: PubMed 23643826Gonnissen 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luzia Valentini, Prof. Dr. principal investigator
Neubrandenburg University of Applied Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Body Weight, run by University of Applied Sciences Neubrandenburg at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luzia Valentini, Prof. Dr. (+49 395 5693 ext. 2512, valentini@hs-nb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting energy expenditure (REE) (kcal) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02682537, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.