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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
INTERVENTION WITH OLIVE OIL EXTRACTS
Group of 20 people will receive olive oil extract supplements and after the washout period will receive placebo.
Intervention: supplementation, food (Dietary Supplement)
INTERVENTION WITH BILBERRY
Group of 20 participants will receive bilberry extract supplements and after the washout period a placebo phase.
Intervention: supplementation, food (Dietary Supplement)
Investigators
Nikolaos Tentolouris
Professor of Medicine
National and Kapodistrian University of Athens
