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

NCT07659028 | Not Yet Recruiting

• 2 other identifiers: 999643007101225248
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes; Obesity & Overweight; Inflamation; Oxidative Stress

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

Outcome Measures

Primary Outcomes (1)

• Changes in inflammatory and oxidative stress markers

  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

  14 weeks

Secondary Outcomes (5)

• Lipid profile

  14 weeks

• Inflammatory profile

  14 weeks

• Anthropometric profile

  14 weeks

• Metabolic profile

  14 weeks

• Microbiome profile

  14 weeks

Study Arms (2)

INTERVENTION WITH OLIVE OIL EXTRACTS

EXPERIMENTAL

Group of 20 people will receive olive oil extract supplements and after the washout period will receive placebo.

Dietary Supplement: supplementation, food

INTERVENTION WITH BILBERRY

EXPERIMENTAL

Group of 20 participants will receive bilberry extract supplements and after the washout period a placebo phase.

Dietary Supplement: supplementation, food

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.

Also known as: Body weight and composition changes, oxidative stress and inflammatory biomarkers, blood samples, urine samples, stool samples

INTERVENTION WITH BILBERRY; INTERVENTION WITH OLIVE OIL EXTRACTS

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old,
• BMI\> 25 kg/m2
• prediabetic stage
• hsCRP\> 2mg/ L
• HbA1c 5,7-6,4%
• Impaired fasting glucose (IFG)
• Caucasian

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Laiko Hospital

Athens, 11527, Greece

Location

MeSH Terms

Conditions

Prediabetic State; Obesity; Overweight

Interventions

Dietary Supplements; Food; Weights and Measures; Oxidative Stress; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Investigative Techniques; Metabolism; Stress, Physiological; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-03

Locations

GR (1)