NCT05679310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

November 30, 2022

Last Update Submit

January 9, 2023

Conditions

Oxidative StressInflammationBody WeightHomocystine; Metabolic Disorder

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • LDL-cholesterol

    Change from Baseline up to 12 weeks

  • HDL-cholesterol

    Change from Baseline up to 12 weeks

  • Glutathione

    Change from Baseline up to 12 weeks

  • Catalase

    Change from Baseline up to 12 weeks

Other Outcomes (2)

  • Total Antioxidant Capacity

    Change from Baseline up to 12 weeks

  • Malonaldehyde

    Change from Baseline up to 12 weeks

Study Arms (1)

Supplement

EXPERIMENTAL

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

Dietary Supplement: Hydroxytyrosol/Essential oils

Interventions

Hydroxytyrosol/Essential oilsDIETARY_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.

Supplement

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ioannina

Ioannina, Epirus, 45110, Greece

Location

MeSH Terms

Conditions

InflammationBody WeightMetabolic Diseases

Interventions

3,4-dihydroxyphenylethanolOils, Volatile

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Patra Vezyraki, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2022

First Posted

January 10, 2023

Study Start

February 10, 2022

Primary Completion

July 6, 2022

Study Completion

September 30, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations

GR(1)