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

Sponsor
National and Kapodistrian University of Athens
Study ID
NCT07659028
Status
Not Yet Recruiting

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Conditions

  • Inflamation
  • Obesity & Overweight
  • Oxidative Stress
  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
30 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jun 22, 2026
Start date
Jul 1, 2026
Status verified
Mar 2026
Primary completion
Jul 1, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: INTERVENTION WITH OLIVE OIL EXTRACTS
    Group of 20 people will receive olive oil extract supplements and after the washout period will receive placebo.
  • Experimental: INTERVENTION WITH BILBERRY
    Group of 20 participants will receive bilberry extract supplements and after the washout period a placebo phase.

Primary Outcome Measure

Changes in inflammatory and oxidative stress markers [ Time Frame: 14 weeks ]

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