Clinical trial NCT05679310: Innovative Biotechnological Production of Antioxidant Products
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Inflammation
Body Weight
Homocystine; Metabolic Disorder
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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)

Primary outcomes:
measure: Homocysteine
timeFrame: Change from Baseline up to 12 weeks
measure: Fasting blood glucose
timeFrame: Change from Baseline up to 12 weeks
measure: oxLDL
timeFrame: Change from Baseline up to 12 weeks
Secondary outcomes:
measure: LDL-cholesterol
timeFrame: Change from Baseline up to 12 weeks
measure: HDL-cholesterol
timeFrame: Change from Baseline up to 12 weeks
measure: Glutathione
timeFrame: Change from Baseline up to 12 weeks
measure: Catalase
timeFrame: Change from Baseline up to 12 weeks
Other outcomes:
measure: Total Antioxidant Capacity
timeFrame: Change from Baseline up to 12 weeks
measure: Malonaldehyde
timeFrame: Change from Baseline up to 12 weeks
Locations:
city: Ioannina
country: Greece
facility: University of Ioannina
state: Epirus
Study officials:
affiliation: University of Ioannina, School of Health Sciences, Department of Medicine, Laboratory of Physiology
name: Patra Vezyraki, PhD
role: PRINCIPAL_INVESTIGATOR
References: