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NCT Number: NCT07659028

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

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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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Body weight and composition changes, oxidative stress and inflammatory biomarkers, blood samples, urine samples, stool samples

Primary outcomes

  1. Changes in inflammatory and oxidative stress markers

    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

Secondary outcomes

  1. Lipid profile

    Time frame: 14 weeks

    Blood samples: TCHOL, HDL, LDL, TG

  2. Inflammatory profile

    Time frame: 14 weeks

    Blood samples: ICAM-1, VCAM-1, CRP-C

  3. Anthropometric profile

    Time frame: 14 weeks

    Body measurements: BMI and body weight changes

  4. Metabolic profile

    Time frame: 14 weeks

    Urine and plasma samples: metabolite profile in urine and plasma

  5. Microbiome profile

    Time frame: 14 weeks

    Stool samples: microbiome diversity, microbiome composition changes, and microbiome functionality

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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