Status:
ENROLLING_BY_INVITATION
Impact of Energy Density on Energy Intake During Bed Rest
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
DLR German Aerospace Center
Conditions:
Bed Rest
Space Analogue
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Brief summary: This study is conducted in the context of a 60 days strict bed-rest study with 6° head-down-tilt (HDT) body position. Food intake can be challenging during bed-rest due to loss of appet...
Eligibility Criteria
Inclusion
- Physically and mentally healthy test subjects that declare their willingness to participate in the entire study and successfully pass the psychological and medical screening
- Aged between 24 and 55 years
- Body mass index between 18 to 28 kg/m2
- Body height between 153 to 190 cm (+/- 2 cm)
- Signed informed consent
- Demonstrable medical insurance and official certificate of absence of criminal record
- No less than 2 SD below the average normal bone mineral density (measured by dual-energy x-ray absorptiometry) for hip and lumbar spine (i.e., mean peak bone mineral density of Caucasian, sex-matched young adults) denoted by T-score (T-score \> -2)
- Demonstrable dentist certificate
- Hormonal contraception for female participants is allowed, but details (manufacturer, doses, dates) must be reported
Exclusion
- Candidate subject exclusion criteria for the study will include the following:
- Any infectious, genetic, autoimmune, endocrinological, hematological, cardiovascular, lung, gastroenterological, kidney, rheumatic, muscle, bone, orthopedic, dermatological, gynecological, urological, ophthalmological, otorhinolaryngological, neurological or psychiatric disease (see at the end of document; a) that precludes a safe participation in the study or might significantly impact scientific results of the study according to the study physician
- Drug, medication or alcohol abuse (regular consumption of more than 30 g alcohol/day)
- Smoker within 6 months prior to enrollment
- Any long-term medication use that might significantly impact scientific results of the study (for instance bisphosphonate therapy, anti-hypertensives, gastro-esophageal reflux).
- Special dietary requests, that cannot be provided by the project team (e.g. vegan, vegetarian or other ineligible diet)
- Claustrophobia
- Increased intraocular pressure
- Hyperopia / Myopia \> +/- 5.0 Diopters
- Astigmatism \> 3 Diopters
- History of laser surgery of the eye, glaucoma and retinal surgery
- Any ocular condition that would significantly impact visual function
- Significant chronic gastro-esophageal reflux precluding a safe participation in the study
- Clinically relevant allergy (e.g. requirement to carry a stand-by emergency injection), that precludes a safe participation in the study
- History of chronic back complaints, that precludes a safe participation in the study
- History of kidney stones
- Anemia: Hemoglobin under normal values (see at the end of document; b). (Normal values of Hemoglobin for men: 13.0-17.5 g/dl; women 12.0-16.0 g/dl)
- Elevated risk of thrombosis (see at the end of document; c)
- Inability to successfully complete a 10-minute upright posture test without clinically relevant orthostatic symptoms
- Current or history of hemorrhagic diathesis or coagulations disorders
- History of spinal cord disease, including radiculopathy, myelopathy, or neuropathy
- History of disorders affecting CSF circulation (i.e. hydrocephalus, idiopathic intracranial hypertension) History of more than one depressive episode and/or history of a severe depressive episode, such as requiring inpatient or intensive outpatient treatment
- Known chronic tinnitus
- Hearing loss (bi-lateral or one-sided) precluding successful participation in the study
- Female candidate is pregnant or breast-feeding
- Female candidate is in menopause or post-menopause, unless on hormone replacement therapy (but not treated with bisphosphonates or anti-resorptives)
- Female candidate stopped hormonal contraception medication up to 3 months prior to study start
- Metal implants (or objects like metallic slivers in the eyes, or bullets or shrapnel in the body) or other kinds of bone synthesis materials, implanted medical devices, tattoos or permanent make-up incompatible with MRI
- Participation in a (clinical) study within the last 3 months before start of this study that significantly confounds participation in the study Any other condition which makes the test subject unsuitable for study inclusion in the opinion of the project team
- Explanations to exclusion criteria (a-c)
- History of single episode of prolonged grief or mild depression with no symptoms in the 12 months prior to study start is acceptable
- Normal values from: https://www.lab-quade.de/leistungen/?idLoc=1
- A thrombosis risk stratification will be conducted according to clinical standards: in the anamnesis, the subject will be extensively questioned for thrombosis risk factors and assessed by means of specific analytical laboratory methods for assessing thrombosis risk using thrombophilia screening
Key Trial Info
Start Date :
September 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06571877
Start Date
September 24 2024
End Date
December 31 2027
Last Update
August 26 2024
Active Locations (1)
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1
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076