Oxidative StressAntiox-PlusNCT05679310
Innovative Biotechnological Production of Antioxidant Products
A study testing Hydroxytyrosol/Essential oils in people with Oxidative Stress and Inflammation, run by University of Ioannina at 1 site in Greece.
Trial summary
Several natural compounds have been explored as immune-boosting, antioxidant, and anti-inflammatory dietary supplements. Amongst them, hydroxytyrosol a natural antioxidant found in olive products, and endemic medicinal plants have attracted the scientific's community and industry's interest. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Inflammation, Body Weight
- What is being tested?
- Hydroxytyrosol/Essential oils
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGreece
- Study dates
- 10 Feb 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 25 and 65 years
- the absence of any chronic health conditions
- adequate understanding of the study
Who cannot join
- the presence of any chronic health conditions (diabetes, hypertension, dyslipidemia)
- intake of nutritional supplements over the past 60 days
- heavy smokers (≥25 cigarettes/day)
- high alcohol use (men >14 drinks/week, women >7 drinks/week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Biotechnological Production of Antioxidant Products of Plant Origin From Microbial Factories, and Essential Oils From the Greek Flora, for the Creation of New Quality Health Products and Nutritional Supplements
Several natural compounds have been explored as immune-boosting, antioxidant, and anti-inflammatory dietary supplements. Amongst them, hydroxytyrosol a natural antioxidant found in olive products, and endemic medicinal plants have attracted the scientific's community and industry's interest. The safety and biological activity of a standardised supplement containing 10 mg of hydroxytyrosol synthesized using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from oregano vulgaris, sage officinalis and crithmum maritimum in an open-label, single-arm, prospective clinical study were studied. The supplement capsules were given to 12 healthy subjects, aged 26-52, once a day for 8 weeks.
Read the detailed description
The study was designed to evaluate the safety and biological activity of the supplement Antiox-Plus: one capsule/day, 15 minutes before their main meal which contained 10 mg of HT, synthesised using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from Origanum vulgare, Sage officinalis and Crithmum maritimum. The volunteers will consume the supplement for 8 weeks. A follow-up analysis will be performed one month after the end of the supplementation period (12 weeks from the initiation of the study). During this time, the participants will consume a placebo.
The volunteers are instructed to maintain their normal dietary habits. The following measurements will be taken: A) Dietary assessment at the beginning of the study (week 0), B) Body composition analysis at the beginning (week 0) and the end of the study (week 8), C) biochemical and laboratory analysis of plasma samples at week 0, 8 and 12.
The volunteers will record their food intake for 3 days (including one day of the weekend) and will fulfil a food frequency questionnaire. Analysis of their data will be done by a certified nutritionist. Nutritional assessment will be performed using the Evexis dietary software. The Tanita Dual Frequency Body Composition Monitor "Innerscan" will be employed to measure weight, muscle mass, muscle quality score, heart rate, body fat (%), physique rating, visceral fat, metabolic age, basal metabolic rate, bone mass, body water (%) and body mass index (BMI) in the morning. Physical activity will be assessed by the Greek version of the short International Physical Activity Questionnaire (IPAQ-short).
- Being tested
- Hydroxytyrosol/Essential oils
- Medical subject headings
- Inflammation, Body Weight, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxytyrosol/Essential oilsDietary supplement
A dietary supplement containing 10 mg of hydroxytyrosol, synthesised using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from oregano vulgaris, sage officinalis and crithmum maritimum.
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | The supplement capsules were given to 12 healthy subjects, aged 26-52, once a day for 8 weeks Receives: Dietary Supplement: Hydroxytyrosol/Essential oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homocysteine
Homocysteine (μmol/L)
Measured: Change from Baseline up to 12 weeks
Fasting blood glucose
Fasting blood glucose (md/dL)
Measured: Change from Baseline up to 12 weeks
oxLDL
oxLDL (mU/mL)
Measured: Change from Baseline up to 12 weeks
Secondary outcomes (4)
LDL-cholesterol
LDL-cholesterol (mg/dL)
Measured: Change from Baseline up to 12 weeks
HDL-cholesterol
HDL-cholesterol (mg/dL)
Measured: Change from Baseline up to 12 weeks
Glutathione
Glutathione (mU/mL)
Measured: Change from Baseline up to 12 weeks
Catalase
Catalase (units/mL)
Measured: Change from Baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start10 Feb 2022
- Primary completion6 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patra Vezyraki, University of Ioannina
- Investigators
- Patra Vezyraki, PhD, Principal investigator, University of Ioannina, School of Health Sciences, Department of Medicine, Laboratory of Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679310
- Sponsor's protocol ID
- 82436
- Acronym
- Antiox-Plus
- Status last verified
- Jan 2023
- First submitted
- 30 Nov 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Biotechnological Production of Antioxidant Products of Plant Origin From Microbial Factories, and Essential Oils From the Greek Flora, for the Creation of New Quality Health Products and Nutritional Supplements
- ClinicalTrials.gov ID
- NCT05679310
- Acronym / sponsor ID
- Antiox-Plus / 82436
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 10 Jan 2023 (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.
Several natural compounds have been explored as immune-boosting, antioxidant, and anti-inflammatory dietary supplements. Amongst them, hydroxytyrosol a natural antioxidant found in olive products, and endemic medicinal plants have attracted the scientific's community and industry's interest. The safety and biological activity of a standardised supplement containing 10 mg of hydroxytyrosol synthesized using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from oregano vulgaris, sage officinalis and crithmum maritimum in an open-label, single-arm, prospective clinical study were studied. The supplement capsules were given to 12 healthy subjects, aged 26-52, once a day for 8 weeks.
Detailed description
The study was designed to evaluate the safety and biological activity of the supplement Antiox-Plus: one capsule/day, 15 minutes before their main meal which contained 10 mg of HT, synthesised using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from Origanum vulgare, Sage officinalis and Crithmum maritimum. The volunteers will consume the supplement for 8 weeks. A follow-up analysis will be performed one month after the end of the supplementation period (12 weeks from the initiation of the study). During this time, the participants will consume a placebo.
The volunteers are instructed to maintain their normal dietary habits. The following measurements will be taken: A) Dietary assessment at the beginning of the study (week 0), B) Body composition analysis at the beginning (week 0) and the end of the study (week 8), C) biochemical and laboratory analysis of plasma samples at week 0, 8 and 12.
The volunteers will record their food intake for 3 days (including one day of the weekend) and will fulfil a food frequency questionnaire. Analysis of their data will be done by a certified nutritionist. Nutritional assessment will be performed using the Evexis dietary software. The Tanita Dual Frequency Body Composition Monitor "Innerscan" will be employed to measure weight, muscle mass, muscle quality score, heart rate, body fat (%), physique rating, visceral fat, metabolic age, basal metabolic rate, bone mass, body water (%) and body mass index (BMI) in the morning. Physical activity will be assessed by the Greek version of the short International Physical Activity Questionnaire (IPAQ-short).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Dietary Supplement: Hydroxytyrosol/Essential oilsThe supplement capsules were given to 12 healthy subjects, aged 26-52, once a day for 8 weeks |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 25 and 65 years
- the absence of any chronic health conditions
- adequate understanding of the study
Key exclusion criteria (4 listed)
- the presence of any chronic health conditions (diabetes, hypertension, dyslipidemia)
- intake of nutritional supplements over the past 60 days
- heavy smokers (≥25 cigarettes/day)
- high alcohol use (men >14 drinks/week, women >7 drinks/week)
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 |
|---|---|---|
| Hydroxytyrosol/Essential oilsA dietary supplement containing 10 mg of hydroxytyrosol, synthesised using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from oregano vulgaris, sage officinalis and crithmum maritimum. | Dietary supplement | Supplement |
Primary outcome
Homocysteine
Time frame: Change from Baseline up to 12 weeks
Homocysteine (μmol/L)
Fasting blood glucose
Time frame: Change from Baseline up to 12 weeks
Fasting blood glucose (md/dL)
oxLDL
Time frame: Change from Baseline up to 12 weeks
oxLDL (mU/mL)
4 secondary outcomes
LDL-cholesterol
Time frame: Change from Baseline up to 12 weeks
HDL-cholesterol
Time frame: Change from Baseline up to 12 weeks
Glutathione
Time frame: Change from Baseline up to 12 weeks
Catalase
Time frame: Change from Baseline up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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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. This study is not recruiting at the moment.
Patra Vezyraki, PhD principal investigator
University of Ioannina, School of Health Sciences, Department of Medicine, Laboratory of Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxytyrosol/Essential oils in people with Oxidative Stress and Inflammation, run by University of Ioannina 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homocysteine (time frame: Change from Baseline up to 12 weeks). The study lists 3 primary outcomes in all. 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 10 Jan 2023.