IC-BASAROTs: Verification of a New Practice Method for More Accurate Bed-side Assessment of Individual Energy Expenditure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,400
- 试验地点
- 6
- 主要终点
- resting energy expenditure (REE) (kcal)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •Orciprenaline
- •Amiodarona
- •corticoid therapy (oral)
结局指标
主要结局
resting energy expenditure (REE) (kcal)
时间窗: 15 minutes
Assessed by indirect calorimetry
次要结局
- Skeletal muscle mass (SMM) (kg)(one single (baseline) measurement under standardized conditions)
- Total body water (TBW) (l)(one single (baseline) measurement under standardized conditions)
- 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)
- Resistance (R) (Ω)(one single (baseline) measurement under standardized conditions)
- Body weight (kg)(one single (baseline) measurement under standardized conditions)
- Fat mass (FM) (kg)(one single (baseline) measurement under standardized conditions)
- Fat-free mass (FFM) (kg)(one single (baseline) measurement under standardized conditions)
- Body height (m)(one single (baseline) measurement under standardized conditions)
- Fat-free mass index (FFMI) (kg/m²)(one single (baseline) measurement under standardized conditions)
- Fat mass index (FMI) (kg/m²)(one single (baseline) measurement under standardized conditions)
- Phase angle (°)(one single (baseline) measurement under standardized conditions)
- Waist circumference (cm)(one single (baseline) measurement under standardized conditions)
- Reactance (Xc) (Ω)(one single (baseline) measurement under standardized conditions)
- International Physical Activity Questionnaire (IPAQ) short form(one single (baseline) interview)
- Extracellular water (ECW) (l)(one single (baseline) measurement under standardized conditions)
研究者
Luzia Valentini
Prof. Dr.
University of Applied Sciences Neubrandenburg