Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

Influence of Bed-Rest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: bed rest, hypocaloric nutrition

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
• Enrollment: 10
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Educational/Counseling/Training
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Drug-induced changes of forearm blood flow

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Walter E Haefeli, MD, Heidelberg University

Study record dates

Study Major Dates

• Study Start: March 1, 2001
• Study Completion: April 1, 2003

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): September 15, 2005
• Last Update Submitted That Met QC Criteria: September 9, 2005
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Other Study ID Numbers: K008