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Completed

NCT Number: NCT00175968

Influence of Bedrest 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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

DLR Institute of Aerospace Medicine

Cologne, North Rhine-Westphalia, D-51170, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bed rest, hypocaloric nutrition

Procedure

Primary outcomes

  1. Drug-induced changes of forearm blood flow

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2003
First posted
Sep 15, 2005
Registry last updated
Sep 15, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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