Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

This study has been completed.
Information provided by:
Heidelberg University Identifier:
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 9, 2005
September 9, 2005
March 2001
Not Provided
Drug-induced changes of forearm blood flow
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
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 Blind
Primary Purpose: Educational/Counseling/Training
Procedure: bed rest, hypocaloric nutrition
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2003
Not Provided

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.
18 Years to 40 Years
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Heidelberg University
Not Provided
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