Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

• Sponsor: Heidelberg University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00175968
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Mar 1, 2001
• Study Completion Date: Apr 1, 2003

Outcome Measures

Primary Outcome Measures

1. Drug-induced changes of forearm blood flow []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00175968
• Other Study ID Numbers: K008
• First Posted: Sep 15, 2005
• Last Update Posted: Sep 15, 2005
• Last Verified: Sep 1, 2005

Study Results

No Results Posted as of Sep 15, 2005