Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00175968
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention Phase
Healthy
Procedure: bed rest, hypocaloric nutrition
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Influence of Bed-Rest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

Further study details as provided by Heidelberg University:

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

Estimated Enrollment: 10
Study Start Date: March 2001
Estimated Study Completion Date: April 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00175968     History of Changes
Other Study ID Numbers: K008
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 23, 2014