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Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
September 9, 2005
September 15, 2005
December 9, 2005
March 2001
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Drug-induced changes of forearm blood flow
Same as current
No Changes Posted
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Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity
Influence of Bed-Rest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity
Aim of the study is to assess the impact of the factors ´bed rest´ and ´hypocaloric nutrition´ on endothelium-dependent vasoreactivity in healthy volunteers.
In a randomized, four-phase cross-over study the effect of simulated microgravity (13 days of bed rest), energetic restriction (-25%, fat reduced), and their combination on endothelium-dependent and -independent vasodilation will be compared with ambulatory control conditions. Using venous occlusion plethysmography cumulative intraarterial dose-response curves to endothelium-dependent (acetylcholine) and -independent (sodium nitroprusside) vasodilators will be constructed in 10 healthy male volunteers before and on day 13 of each of the four intervention periods.
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Procedure: bed rest, hypocaloric nutrition
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2003
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Inclusion Criteria:´

  • Healthy, male volunteers, age: 18-40
  • Able and willing to give written informed consent

Exclusion Criteria:

  • Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, smoking, hyperhomocysteinaemia)
  • Regular medication and/or treatment with drugs within the last 4-6 weeks (exclusion has to be decided in each case)
  • Acute or chronic illness
  • Participation in clinical trial/blood donation within 2 month before the study
  • Nicotine during 1 year before the study; drug and/or alcohol abuse.
Sexes Eligible for Study: Male
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Heidelberg University
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Principal Investigator: Walter E Haefeli, MD Heidelberg University
Heidelberg University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP