Human Pilot Study for the Investigation of the Role of Bilberry and Olive Bioactives on Oxidative Stress Parameters and Inflammatory Markers.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: supplementation, food.
- Who it may be relevant to
- Registry conditions: Prediabetes, Obesity & Overweight, Inflamation, Oxidative Stress. Basic parameters: 30 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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 supplement supplementation, 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.
Primary outcome measures
- Changes in inflammatory and oxidative stress markers [Time frame: 14 weeks]
Secondary outcome measures (5)
- Lipid profile [Time frame: 14 weeks]
- Inflammatory profile [Time frame: 14 weeks]
- Anthropometric profile [Time frame: 14 weeks]
- Metabolic profile [Time frame: 14 weeks]
- Microbiome profile [Time frame: 14 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Greece · 1 center
- Laiko Hospital — Athens
Identifiers
NCT: NCT07659028 · 999643007 · 101225248