Innovative Biotechnological Production of Antioxidant Products

NCT ID: NCT05679310

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2022-09-30

Brief 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. 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).

Conditions

Oxidative Stress; Inflammation; Body Weight; Homocystine; Metabolic Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Supplement

The supplement capsules were given to 12 healthy subjects, aged 26-52, once a day for 8 weeks

Group Type: EXPERIMENTAL

Hydroxytyrosol/Essential oils

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ioannina

OTHER

Sponsor Role: lead

Responsible Party

Patra Vezyraki

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patra Vezyraki, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ioannina, School of Health Sciences, Department of Medicine, Laboratory of Physiology

Locations

University of Ioannina

Ioannina, Epirus, Greece

Countries

Greece

Other Identifiers

82436

Identifier Type: -

Identifier Source: org_study_id