An observational study in Healthy, Body Weight and Overweight, sponsored by University of Applied Sciences Neubrandenburg. Status unknown at 6 sites in Germany. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-11.
Sponsored by University of Applied Sciences Neubrandenburg · Observational
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).
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 154 across 424 observational studies indexed under Overweight.
Browse Overweight studies →This is the only study on the registry with University of Applied Sciences Neubrandenburg as lead sponsor.
Compared within Overweight, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Body Weight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Age: 18 - 100 Years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
Age: 18 - 100 years
resting energy expenditure (REE) (kcal)
Assessed by indirect calorimetry
Time frame: 15 minutes
blood pressure (mm Hg)
upper arm measurement by certified medical device
Time frame: one single (baseline) measurement under standardized conditions
Body temperature (°C)
measured axillar, by infra-red ear thermometer and non-contact thermoscan
Time frame: one single (baseline) measurement under standardized conditions
Heart rate (bpm)
measured by heart rate band and blood pressure device
Time frame: one single (baseline) measurement under standardized conditions
Body weight (kg)
measured by electronic scale integrated in BIA device
Time frame: one single (baseline) measurement under standardized conditions
Body height (m)
measured by digital stationary stadiometer
Time frame: one single (baseline) measurement under standardized conditions
Fat mass (FM) (kg)
measured by bioelectrical impedance analysis (BIA)
Time frame: one single (baseline) measurement under standardized conditions
Fat-free mass (FFM) (kg)
measured by bioelectrical impedance Analysis (BIA)
Time frame: one single (baseline) measurement under standardized conditions
Fat-free mass index (FFMI) (kg/m²)
measured by bioelectrical impedance Analysis (BIA)
Time frame: one single (baseline) measurement under standardized conditions
Fat mass index (FMI) (kg/m²)
measured by bioelectrical impedance Analysis (BIA)
Time frame: one single (baseline) measurement under standardized conditions
Skeletal muscle mass (SMM) (kg)
measured by bioelectrical impedance Analysis (BIA)
Time frame: one single (baseline) measurement under standardized conditions
Total body water (TBW) (l)
measured by bioelectrical impedance Analysis (BIA)
Time frame: one single (baseline) measurement under standardized conditions
Extracellular water (ECW) (l)
measured by bioelectrical impedance Analysis (BIA)
Time frame: one single (baseline) measurement under standardized conditions
Resistance (R) (Ω)
measured by bioelectrical impedance Analysis (BIA)
Time frame: one single (baseline) measurement under standardized conditions
Reactance (Xc) (Ω)
measured by bioelectrical impedance Analysis (BIA)
Time frame: one single (baseline) measurement under standardized conditions
Phase angle (°)
measured by bioelectrical impedance Analysis (BIA)
Time frame: one single (baseline) measurement under standardized conditions
Waist circumference (cm)
measured by measuring tape
Time frame: one single (baseline) measurement under standardized conditions
International Physical Activity Questionnaire (IPAQ) short form
Time frame: one single (baseline) interview
Plan to share: 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.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.