healthy subjects I95.1
Conditions
Interventions
Group 1: standardized hypercaloric nutrition for 4 days, 25% higher than their individual energy requirements
washout phase of 23 days
Group 2: standardized normocaloric nutrition for 4 days, following their individual energy requirements
washoutphase of 23 days
Sponsors
DLR - Institut für Luft- und RaumfahrtInstitut für Luft- und Raumfahrtmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: -Between 18-40 years -Informed consent must be signed before any study specific tests or procedures -Body Mass Index (BMI) of 19-25 kg/m2, (Non-obese) - healthy - non-smoker -No body weight changes of >±3 kg within 3 month before study onset
Exclusion criteria
Exclusion criteria: -Clinically relevant findings in ECG -History of relevant and not cured cardiac rhythm disorders -Clinically relevant deviations of labratory Parameters from reference range at Screening, especially hepatic parameters, renal Parameters, thyroid stimulating Hormone (TSH), Coagulation Parameters, Glucose parameters, infammation or fat parameters -Claustrophobia -clinically relevant findings in medical history e.g. history or currently existing relevant diseases of vital organs, central nervous system (for example seizures) or other organs (e.g. diabetes mellitus). -History of postural or neurological syncope
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in orthostatic tolerance as time to presyncope (in minutes). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Plasma volume (CO rebreathing technique (CORB)) -Free fatty acid- and triglyceride concentrations -Changes in leptin concentrations -Changes in glucose tolerance and insulin sensitivity calculated by certain indices (HOMA-IR, ISI, hepatic insulin sensitivity, muscle insulin sensitivity) -Body composition by bio-electric impedance analysis (BIA) and whole-body plethysmography (BodPod) | — |
Countries
Germany
Contacts
Public ContactAnn Charlotte Ewald
DLR - Institut für Luft- und Raumfahrtmedizin
Outcome results
None listed