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Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

H

Heidelberg University

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Procedure: bed rest, hypocaloric nutrition

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Educational/Counseling/Training

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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