Innovative Biotechnological Production of Antioxidant Products (Antiox-Plus)

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Body Weight; Oxidative Stress; Homocystine; Metabolic Disorder
• Intervention / Treatment: Dietary supplement: Hydroxytyrosol/Essential oils

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Epirus
    • Ioannina, Epirus, Greece, 45110
      • University of Ioannina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supplement; The supplement capsules were given to 12 healthy subjects, aged 26-52, once a day for 8 weeks	Dietary supplement: Hydroxytyrosol/Essential oils; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homocysteine	Homocysteine (μmol/L)	Change from Baseline up to 12 weeks
Fasting blood glucose	Fasting blood glucose (md/dL)	Change from Baseline up to 12 weeks
oxLDL	oxLDL (mU/mL)	Change from Baseline up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-cholesterol	LDL-cholesterol (mg/dL)	Change from Baseline up to 12 weeks
HDL-cholesterol	HDL-cholesterol (mg/dL)	Change from Baseline up to 12 weeks
Glutathione	Glutathione (mU/mL)	Change from Baseline up to 12 weeks
Catalase	Catalase (units/mL)	Change from Baseline up to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Antioxidant Capacity	Total Antioxidant Capacity (mM a-tocopherol)	Change from Baseline up to 12 weeks
Malonaldehyde	Malonaldehyde (μΜ)	Change from Baseline up to 12 weeks

Collaborators and Investigators

• Sponsor: University of Ioannina
• Investigators: Principal Investigator: Patra Vezyraki, PhD, University of Ioannina, School of Health Sciences, Department of Medicine, Laboratory of Physiology

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): July 6, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Body Weight; Metabolic Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; 3,4-dihydroxyphenylethanol
• Other Study ID Numbers: 82436

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No