Healthy
Conditions
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.
Interventions
PROCEDUREbed rest, hypocaloric nutrition
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
ECT
Masking
SINGLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug-induced changes of forearm blood flow | — |
Countries
Germany
Outcome results
None listed