Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

This study has been completed.

First Received: September 9, 2005 No Changes Posted

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00175968

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 I

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Single Blind, Active Control, Crossover Assignment
Official Title:	Influence of Bed-Rest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

Further study details as provided by University of Heidelberg:

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, North-Rhine-Westphalia
DLR Institute of Aerospace Medicine
Cologne, North-Rhine-Westphalia, Germany, D-51170

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Walter E Haefeli, MD

University of Heidelberg

More Information

No publications provided

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

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 02, 2009