Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07659028
Acronym
BIOTRANSFORM
Enrollment
60
Registered
2026-06-22
Start date
2026-07-01
Completion date
2029-10-31
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflamation, Obesity & Overweight, Oxidative Stress, Prediabetes

Keywords

FOOD BIOACTIVES, FOOD BIOACTIVE COMPOUNDS, OLIVE PRODUCTS, BILBERRY PRODUCTS, OLEA EUROPEA L., BILBERRY, VACCINUM MYRTILLOUS L., GUT MICROBIOME, MICROBIOME MAPPING, IN VITRO, IN SILICO, BIOACTIVE COMPOUNDS, METABOLISM

Brief 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.

Interventions

DIETARY_SUPPLEMENTsupplementation, food

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.

Sponsors

National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in inflammatory and oxidative stress markers14 weeksThe 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

MeasureTime frameDescription
Lipid profile14 weeksBlood samples: TCHOL, HDL, LDL, TG
Inflammatory profile14 weeksBlood samples: ICAM-1, VCAM-1, CRP-C
Anthropometric profile14 weeksBody measurements: BMI and body weight changes
Metabolic profile14 weeksUrine and plasma samples: metabolite profile in urine and plasma
Microbiome profile14 weeksStool samples: microbiome diversity, microbiome composition changes, and microbiome functionality

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026