Clinical trial

Human Pilot Study for the Investigation of the Role of Bilberry and Olive Bioactives on Oxidative Stress Parameters and Inflammatory Markers.

Opening soon · Not applicable · 1 countries · Registry ID NCT07659028

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 50 Years
SexAll
Healthy volunteersAccepted
ConditionPrediabetes, Obesity & Overweight, Inflamation, Oxidative Stress

Full registry criteria

Inclusion Criteria: * 30-50 years old, * BMI\> 25 kg/m2 * prediabetic stage * hsCRP\> 2mg/ L * HbA1c 5,7-6,4% * Impaired fasting glucose (IFG) * Caucasian Exclusion Criteria: * No signed informed consent * Supplementation or probiotic usage in the past 8 weeks * Chronic gastrointestinal, inflammatory or metabolic diseases * Alcohol misuse * Pregnancy or breastfeeding * Acute infection during the past month

Treatments and study arms

supplementation, food

Dietary Supplement

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.

Primary outcomes

Changes in inflammatory and oxidative stress markers14 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Laiko Hospital🇬🇷 Athens, Greece
NIKOLAOS TENTOLOURIS, PROFESSOR MD, PHDContact