Laiko Hospital
Athens, 11527, Greece
NCT Number: NCT07659028
Numerous plant-based foods contain bioactive compounds, in particular polyphenols, which have antioxidant, anti-inflammatory, and metabolic regulatory effects. These so-called food bioactives (FB) are converted in the human organism, in particular by the gut microbiota and microsomal (liver/intestinal) metabolism, into numerous metabolites, which often represent the actual biologically active molecules. As part of the European HORIZON-MSCA Doctoral Network "BioTransform," two such food models are being studied as examples: 1. Olive products (Olea europaea L.) - representative of the Mediterranean diet, rich in secoiridoids and phenylethanols (especially hydroxytyrosol and tyrosol). 2.
Bilberry /blueberry (Vaccinium myrtillus L.) - representative of the Central European diet, rich in anthocyanosides. Two parallel human intervention studies will be conducted, one in Graz (WP1, DC5) and one in Athens (WP1, DC3). These pilot studies will generate biological samples (blood, urine, stool) and investigate the extent to which taking these standardized dietary supplements influences glucose metabolism and markers of oxidative stress and low-grade inflammation.
Trial opening soon.
Get Notified30 year–50 year
All sexes
Interventional
Not applicable
Athens, 11527, Greece
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Through this pilot clinical study, the possible change of inflammatory and oxidative stress biomarkers in prediabetic, overweigh/ obese people will be observed. Blood, urine and stool samples will be collected, while weight mangment will also be controlled.
Other names: Body weight and composition changes, oxidative stress and inflammatory biomarkers, blood samples, urine samples, stool samples
Time frame: 14 weeks
The changes in the inflammatory and oxidative stress markers will be assessed through blood samples and the biomarkers: hsCRP, IL-6, TNF-a, total antioxidant capacity, ratio glutathione/ oxidiced glutathion
Time frame: 14 weeks
Blood samples: TCHOL, HDL, LDL, TG
Time frame: 14 weeks
Blood samples: ICAM-1, VCAM-1, CRP-C
Time frame: 14 weeks
Body measurements: BMI and body weight changes
Time frame: 14 weeks
Urine and plasma samples: metabolite profile in urine and plasma
Time frame: 14 weeks
Stool samples: microbiome diversity, microbiome composition changes, and microbiome functionality
National and Kapodistrian University of Athens
Other
A Blinded Placebo-controlled Human Pilot Study for the Investigation of the Role of Bilberry and Olive Bioactives on Oxidative Stress Parameters and Inflammatory Markers. Relevance in European Population
Acronym: BIOTRANSFORM
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