PrediabetesBIOTRANSFORMNCT07659028
Human Pilot Study for the Investigation of the Role of Bilberry and Olive Bioactives on Oxidative Stress Parameters and Inflammatory Markers.
A study testing supplementation, food in people with Prediabetes and Obesity & Overweight, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Obesity & Overweight, Inflamation
- What is being tested?
- supplementation, food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2026to 31 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 30-50 years old,
- BMI> 25 kg/m2
- prediabetic stage
- hsCRP> 2mg/ L
- HbA1c 5,7-6,4%
- Impaired fasting glucose (IFG)
- Caucasian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site
Laiko Hospital
Athens, 11527
NIKOLAOS TENTOLOURIS, PROFESSOR MD, PHD, +30 2132061061, ntentol@meduoa.gr
About this study
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
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
- Being tested
- supplementation, food
- 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
- Medical subject headings
- Prediabetic State, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplementation, foodDietary supplement
Also called Body weight and composition changes, oxidative stress and inflammatory biomarkers, blood samples, urine samples
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 group | Role | What they receive |
|---|---|---|
| INTERVENTION WITH OLIVE OIL EXTRACTS | Experimental | Group of 20 people will receive olive oil extract supplements and after the washout period will receive placebo. Receives: 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. Receives: Dietary Supplement: supplementation, food |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 weeks
Secondary outcomes (5)
Lipid profile
Blood samples: TCHOL, HDL, LDL, TG
Measured: 14 weeks
Inflammatory profile
Blood samples: ICAM-1, VCAM-1, CRP-C
Measured: 14 weeks
Anthropometric profile
Body measurements: BMI and body weight changes
Measured: 14 weeks
Metabolic profile
Urine and plasma samples: metabolite profile in urine and plasma
Measured: 14 weeks
Microbiome profile
Stool samples: microbiome diversity, microbiome composition changes, and microbiome functionality
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Tentolouris, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659028
- Sponsor's protocol ID
- 999643007
- Other IDs
- 101225248
- Acronym
- BIOTRANSFORM
- Status last verified
- Mar 2026
- First submitted
- 9 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07659028
- Acronym / sponsor ID
- BIOTRANSFORM / 999643007
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION WITH OLIVE OIL EXTRACTS | Experimental | Dietary Supplement: supplementation, foodGroup of 20 people will receive olive oil extract supplements and after the washout period will receive placebo. |
| INTERVENTION WITH BILBERRY | Experimental | Dietary Supplement: supplementation, foodGroup of 20 participants will receive bilberry extract supplements and after the washout period a placebo phase. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 30-50 years old,
- BMI> 25 kg/m2
- prediabetic stage
- hsCRP> 2mg/ L
- HbA1c 5,7-6,4%
Key exclusion criteria (6 listed)
- No signed informed consent
- Supplementation or probiotic usage in the past 8 weeks
- Chronic gastrointestinal, inflammatory or metabolic diseases
- Alcohol misuse
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplementation, foodAlso: Body weight and composition changes, oxidative stress and inflammatory biomarkers, blood samples, urine samplesThrough 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. | Dietary supplement | INTERVENTION WITH BILBERRY, INTERVENTION WITH OLIVE OIL EXTRACTS |
Primary outcome
Changes in inflammatory and oxidative stress markers
Time frame: 14 weeks
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplementation, food in people with Prediabetes and Obesity & Overweight, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in inflammatory and oxidative stress markers (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.