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Investigate the effects of a spermidine supplementation on immune system and inflammatory parameters in old and young adults

Not Applicable
Conditions
The aim of our study is to investigate the effect of a short-term spermidine supplementation on inflammatory and immune system parameters as well as polyamine concentrations in blood of old and young adults.
Registration Number
DRKS00025879
Lead Sponsor
Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke (DIfE)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
40
Inclusion Criteria

• Young adults: age: 25-40 years; BMI: 20-30 kg/m²; no chronic medication except for oral contraceptives;
• Old adults: age: 70-90 years; BMI: 20-30 kg/m²;
• No limitations in ‘’activities of daily living’’;
• Subjects must be able to consent as defined by law.

Exclusion Criteria

• Pregnancy/breastfeeding;
• Existing or past immune diseases such as leukemia, lymphoma, malignant neoplasms affecting bone marrow and lymphatic system, HIV or AIDS;
• Self-reported severe or active medical conditions such as arteriosclerosis, advanced cardiac or respiratory disease, such as chronic obstructive pulmonary disease (COPD; GOLD-Stadium =3 (Global Initiative for Chronic Obstructive Lung Disease”-classification)) or heart failure (NYHA =3 (New York Heart Association));
• Self-reported neurological or mental impairment;
• Self-reported severe liver, kidney, or metabolic disease, such as liver cirrhosis (Child Pugh Score =2) or kidney disease (Stadium =3);
• Drug/medication/alcohol dependence;
• Existing polyamine supplementation;
• Known intolerances or allergies to wheat germ, gluten, or histamine.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Investigate the effect of a spermidine intervention on inflammatory parameters by comparing concentrations of inflammatory parameters before and after an intervention with either a spermidine or a placebo supplement, as well as by comparisons between young group and old group.<br>Blood samplings occur before and after the 20-day intervention phase, and plasma, serum as well as blood cells will be extracted and stored at -80°C until laboratory analyses. Inflammatory parameters like C-reactive protein (CRP), tumor necrosis factor-a (TNF-a), interleukin 6 (IL-6) and parameters like Insulin-like growth factor 1 (IGF-1) in serum will be measured by commercial ELISA Kits.<br>
Secondary Outcome Measures
NameTimeMethod
Investigate the effect of a spermidine intervention on specific blood parameters and molecular processes by comparing concentrations before and after an intervention with either a spermidine or a placebo supplement, as well as by comparisons between young group and old group.<br>Blood samplings occur before and after the 20-day intervention phase, and plasma, serum as well as blood cells will be extracted and stored at -80°C until laboratory analyses.<br>T-cell activity, autophagy and hypusine levels in PBMCs will be measured by molecular biological methods. Spermidine and polyamine concentrations in whole blood, plasma, serum and blood cells will be measured by LC-MS methods. Protein expression levels in whole blood will be measured by proteome analyses, so called proteomics.
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