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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014