Trial document




drksid header

  DRKS00020750

Trial Description

start of 1:1-Block title

Title

Effects of hypercaloric nutrition on orthostatic tolerance

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

HyNu-OT

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The ability of the body to adapt the function of the cardiovascular system to the upright position is called orthostasis. In the event of a malfunction of orthostasis, symptoms such as dizziness, ringing in the ears, palpitations, nausea and weakness occur, sometimes forcing the patient to sit or lie down. If one reacts too late to these symptoms, a drop in blood pressure and heart rate occurs, which means that the brain is no longer supplied with sufficient oxygen, which ultimately leads to a brief unconsciousness (syncope). The length of time until the symptoms appear is called orthostasis tolerance. These syncopations can considerably reduce the quality of life and lead to fall injuries.
Syncopes also represent a considerable safety problem in space medicine after returning from longer stays in weightlessness. Therefore it would be desirable to prepare the astronaut in weightlessness, e.g. by special nutrition, for his return to Earth. In previous studies it could already be shown that a negative energy balance (i.e. less energy supply than the body needs) favours the occurrence of a syncope.
The hypothalamus, a part of the brain, plays an important role in regulating metabolism and food intake. The hypothalamus contains neurons that interact with metabolic hormones. In general, the hypothalamus controls appetite. Lesions or damage in the hypothalamus lead to loss of appetite and weight or to abnormal closeness and obesity, depending on the location of the damage.
Using functional magnetic resonance imaging, the basic functions of the hypothalamus, which are activated by controlled sugar uptake, will be investigated. This will provide basic insights in healthy people.
Therefore, this study will investigate how a four-day hypercaloric diet, i.e. a diet with increased energy intake, affects orthostasis tolerance.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Syncope is a common problem that affects all age groups and occurs in 4% of the population. It is one of the main causes for attending an emergency room and is responsible for 0.77% of hospital admissions in the United States and between 0.9–1.2% of hospital admissions in Europe. Although substantive progress has been made, the understanding of the pathophysiology is still incomplete. The commonest cause, irrespective of age, sex, or comorbidity is vasovagal. Vasovagal syncope may limit quality of life considerably and may lead to injuries because of fainting. A vasovagal response can also be triggered in healthy volunteers subjected to a sufficiently severe orthostatic stress. Up to now, NO pharmacological therapies with proven efficacy exist. A more cost effective and safer non-pharmacological therapeutic approach is definitely desirable.
Up to 64% of the astronauts return to Earth with an increased risk of orthostatic intolerance. In astronauts, reduction in blood volume altered cardiovascular neurohumoral regulation, diminished carotid-cardiac baroreflex responsiveness, augmented peripheral pooling (e.g. legs, abdomen) and venous compliance during microgravity seem to play a significant role.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

not intended

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00020750
  •   2020/02/06
  •   [---]*
  •   yes
  •   Approved
  •   201871, Ethikkommission der Ärztekammer Nordrhein
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I95.1 -  Orthostatic hypotension
  •   healthy subjects
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   standardized hypercaloric nutrition for 4 days, 25% higher than their individual energy requirements;
    washout phase of 23 days
  •   standardized normocaloric nutrition for 4 days, following their individual energy requirements;
    washoutphase of 23 days
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Other
  •   Prevention
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Changes in orthostatic tolerance as time to presyncope (in minutes).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

-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)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2020/02/16
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   40   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • DLR - Institut für Luft- und RaumfahrtInstitut für Luft- und Raumfahrtmedizin
    • Linder Höhe
    • 51147  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   +492203601-0
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institut für Luft- und Raumfahrtmedizin des DLRs (Helmholzgesellschaft)
    • Mr.  Prod. Dr. med.  Jens  Jordan 
    • Linder Höhe
    • 51147  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • DLR - Institut für Luft- und Raumfahrtmedizin
    • Ms.  Ann Charlotte  Ewald 
    • Linder Höhe
    • 51147  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • DLR - Institut für Luft- und RaumfahrtInstitut für Luft- und Raumfahrtmedizin
    • Linder Höhe
    • 51147  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   +492203601-0
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.