Innovative Biotechnological Production of Antioxidant Products

Inflammation Clinical Trial

— Antiox-Plus  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05679310
• Other study ID #: 82436
• Status: Completed
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: University of Ioannina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 30, 2022
• Est. primary completion date: July 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Greece	University of Ioannina	Ioannina	Epirus

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Antioxidant Capacity	Total Antioxidant Capacity (mM a-tocopherol)	Change from Baseline up to 12 weeks
Other	Malonaldehyde	Malonaldehyde (µ?)	Change from Baseline up to 12 weeks
Primary	Homocysteine	Homocysteine (µmol/L)	Change from Baseline up to 12 weeks
Primary	Fasting blood glucose	Fasting blood glucose (md/dL)	Change from Baseline up to 12 weeks
Primary	oxLDL	oxLDL (mU/mL)	Change from Baseline up to 12 weeks
Secondary	LDL-cholesterol	LDL-cholesterol (mg/dL)	Change from Baseline up to 12 weeks
Secondary	HDL-cholesterol	HDL-cholesterol (mg/dL)	Change from Baseline up to 12 weeks
Secondary	Glutathione	Glutathione (mU/mL)	Change from Baseline up to 12 weeks
Secondary	Catalase	Catalase (units/mL)	Change from Baseline up to 12 weeks