Status:

COMPLETED

Planetary Habitat Simulation: Nutrition Studies

Lead Sponsor:

University of Nottingham

Collaborating Sponsors:

Jozef Stefan Institute

KTH Royal Institute of Technology

Conditions:

Hypoxia

Eligibility:

MALE

25-45 years

Phase:

NA

Brief Summary

A loss of body weight has been documented in lowland-living individuals when exposed to hypoxic environments, such as at high altitude, or under laboratory conditions. A reduction in appetite and ener...

Detailed Description

A loss of body weight has been documented in lowland-living individuals when exposed to hypoxic environments, such as at high altitudes, or under laboratory conditions. This weight loss has been attri...

Eligibility Criteria

Inclusion

  • Physically and mentally healthy subjects
  • Body mass index \< 25 kg/m2
  • Height 158 - 190 cm
  • Waist circumference \< 94 cm
  • Volunteers that are able to declare their willingness to participate in the entire study
  • Willing to be assigned randomly to the three groups
  • Successfully passing the psychological and medical screening
  • competent to sign informed consent
  • Slovenian social insurance
  • English language fluency

Exclusion

  • Medication required that may interfere with the interpretation of the results
  • Bone mineral density (as measured by DEXA) more than 1.5 standard deviations \< t score
  • Recent sub-standard nutritional status
  • Family history of thrombosis or positive response in thrombosis screening procedure.
  • (Biochemical analysis of the following parameters: ATIII, High sensitive C-reactive protein, S-Akt., Factor V-Leiden, Prothrombin, Lupus-partial thromboplastin time, Factor II)
  • History of: thyroid dysfunction, renal stones, diabetes, allergies, hypertension, hypocalcemia, uric acidaemia, lipidaemia, or hyperhomocysteinaemia
  • Gastro-esophageal reflux disease or renal function disorder, Hiatus hernia
  • History of medical illness
  • Smoker within six months prior to the start of the study
  • Abuse of drugs, medicine or alcohol
  • Participation in another study up to two months before study onset
  • No signed consent form before the onset of the experiment
  • Blood donors in the past three months before the onset of the experiment
  • Vegetarian and Vegans
  • Migraines
  • History of orthostatic intolerance
  • History of vestibular disorders
  • Claustrophobia
  • metallic implants, osteosynthesis material
  • Chronic back pain

Key Trial Info

Start Date :

March 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2014

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT02293772

Start Date

March 1 2012

End Date

October 1 2014

Last Update

March 15 2019

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Planetary Habitat Simulation: Nutrition Studies | DecenTrialz