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

NCT07659028 — Not applicable, Not yet recruiting, 60 participants, National and Kapodistrian University of Athens

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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

Registry	NCT07659028, acronym BIOTRANSFORM
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: single, prevention
Enrollment	60 (Estimated)
Sponsor	National and Kapodistrian University of Athens (Other)
Conditions	Prediabetes, Obesity & Overweight, Inflamation, Oxidative Stress
Interventions	supplementation, food (Dietary supplement)
Dates	start 2026-07-01 (estimated), primary completion 2029-07-01 (estimated), completion 2029-10-31 (estimated), first posted 2026-06-22, last updated 2026-06-22
Locations	1 site in Greece

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
INTERVENTION WITH OLIVE OIL EXTRACTS	Experimental	Dietary Supplement: supplementation, food	Group of 20 people will receive olive oil extract supplements and after the washout period will receive placebo.
INTERVENTION WITH BILBERRY	Experimental	Dietary Supplement: supplementation, food	Group of 20 participants will receive bilberry extract supplements and after the washout period a placebo phase.

supplementation, food (Dietary supplement), also known as Body weight and composition changes, oxidative stress and inflammatory biomarkers, blood samples, urine samples, stool samples: 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.

+Outcome measures

Primary outcomes

Changes in inflammatory and oxidative stress markers [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

Secondary outcomes

Lipid profile [14 weeks]: Blood samples: TCHOL, HDL, LDL, TG
Inflammatory profile [14 weeks]: Blood samples: ICAM-1, VCAM-1, CRP-C
Anthropometric profile [14 weeks]: Body measurements: BMI and body weight changes
Metabolic profile [14 weeks]: Urine and plasma samples: metabolite profile in urine and plasma
Microbiome profile [14 weeks]: Stool samples: microbiome diversity, microbiome composition changes, and microbiome functionality

+Eligibility

Sex: All, ages: 30 Years to 50 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Laiko Hospital	Athens	Greece