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Characterisation of the postprandial pharmacokinetics of spermidine in humans. Randomised, placebo-controlled, single-centre study in healthy volunteers; two-arm cross-over design with washout phase

Not Applicable
Conditions
healthy subjects
Registration Number
DRKS00029397
Lead Sponsor
Institut für Ernährungsmedizin, Universitätsklinikum Schleswig-Holstein
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
12
Inclusion Criteria

a) women and men aged 18 - 45 years old
b) sufficient knowledge of German to understand the study documents and the procedure

Exclusion Criteria

a) BMI < 18 kg/m² or > 29.9 kg/m²
b) acute illness
c) history of food allergy (especially soy protein allergy)
d) intake of medicines and food supplements during the period 48 h before the start of the study until the end of the study (exception: oral contraceptives)
e) consumption of illegal substances
f) pregnancy and breastfeeding
g) shift work
h) strict vegan diet

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
time-dependent concentration course of putrescine, spermidine and spermine in blood and saliva (quantified by LC-GC-MS)
Secondary Outcome Measures
NameTimeMethod
metabolite spectrum in blood (quantified by NMR metabolomics)
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