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Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

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ClinicalTrials.gov Identifier: NCT00175968
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Sponsor:
Information provided by:
Heidelberg University

Brief Summary:
Aim of the study is to assess the impact of the factors ´bed rest´ and ´hypocaloric nutrition´ on endothelium-dependent vasoreactivity in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Procedure: bed rest, hypocaloric nutrition Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Official Title: Influence of Bed-Rest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity
Study Start Date : March 2001
Estimated Study Completion Date : April 2003



Primary Outcome Measures :
  1. Drug-induced changes of forearm blood flow


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175968


Locations
Germany
DLR Institute of Aerospace Medicine
Cologne, North-Rhine-Westphalia, Germany, D-51170
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Walter E Haefeli, MD Heidelberg University

ClinicalTrials.gov Identifier: NCT00175968     History of Changes
Other Study ID Numbers: K008
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 15, 2005
Last Verified: September 2005