Influence of Bedrest and Hypocaloric Nutrition on Endothelium-Dependent Vasoreactivity

Heidelberg University10 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

ECT

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

bed rest, hypocaloric nutritionPROCEDURE

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

DLR Institute of Aerospace Medicine

Cologne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Drug-induced changes of forearm blood flow

Data from ClinicalTrials.gov

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