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Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

Phase 1
Completed
Conditions
Healthy
Registration Number
NCT00175968
Lead Sponsor
Heidelberg University
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
10
Inclusion Criteria

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  • 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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Drug-induced changes of forearm blood flow
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

DLR Institute of Aerospace Medicine

🇩🇪

Cologne, North-Rhine-Westphalia, Germany

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