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Completed

NCT Number: NCT05679310

Innovative Biotechnological Production of Antioxidant Products

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ioannina

Ioannina, Epirus, 45110, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 25 and 65 years
  • the absence of any chronic health conditions
  • adequate understanding of the study

Exclusion criteria

  • 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)

Treatment and study plan

Hydroxytyrosol/Essential oils

Dietary 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.

Primary outcomes

  1. Homocysteine

    Time frame: Change from Baseline up to 12 weeks

    Homocysteine (μmol/L)

  2. Fasting blood glucose

    Time frame: Change from Baseline up to 12 weeks

    Fasting blood glucose (md/dL)

  3. oxLDL

    Time frame: Change from Baseline up to 12 weeks

    oxLDL (mU/mL)

Secondary outcomes

  1. LDL-cholesterol

    Time frame: Change from Baseline up to 12 weeks

    LDL-cholesterol (mg/dL)

  2. HDL-cholesterol

    Time frame: Change from Baseline up to 12 weeks

    HDL-cholesterol (mg/dL)

  3. Glutathione

    Time frame: Change from Baseline up to 12 weeks

    Glutathione (mU/mL)

  4. Catalase

    Time frame: Change from Baseline up to 12 weeks

    Catalase (units/mL)

Other outcomes

  1. Total Antioxidant Capacity

    Time frame: Change from Baseline up to 12 weeks

    Total Antioxidant Capacity (mM a-tocopherol)

  2. Malonaldehyde

    Time frame: Change from Baseline up to 12 weeks

    Malonaldehyde (μΜ)

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study 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

Acronym: Antiox-Plus

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2023
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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