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Sideritis Supplementation, Oxidative Stress and Health

NCT ID: NCT05729659

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-10-01

Brief Summary

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The aim of the present clinical study is to estimate the efficacy of a Sideritis Scardica extract (SidTea+), derived from the Greek mountain Taygetos, in regulating antioxidant and health biomarkers in healthy adults.

Detailed Description

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Introduction: The mountain tea of genus Sideritis has more than 150 species, which are mainly distributed in the Mediterranean area. In the literature, extensive reference is made to the secondary metabolites of Sideritis, the main ones of which are terpenoids (i.e., iridoids and kauranes) and phenolic derivatives (i.e., flavonoids, phenolic acids, phenylethanoid glycosides). Polyphenols exhibit a wide range of biological activities, such as anti-atherogenic, anti-cancer, anti-mutagenic, anti-inflammatory and antimicrobial properties. Among phenolic derivatives, major significance is given to flavonoids, due to their antioxidant, anti-inflammatory, antibacterial, antiviral and anti-allergic properties in various pathologies. Flavonoids mainly act as antioxidants, inhibiting free radical-induced cytotoxicity and lipid peroxidation. Moreover, these compounds are known to inhibit tumor growth and proliferation and act as weak agonists or antagonists of estrogens by regulating endogenous hormonal activity. In these ways, they can protect against chronic diseases such as atherosclerosis and cancer and regulate menopausal symptoms.

Purpose: This study aims to investigate the effect of a Sideritis Scardica extract (SidTea+) supplement from the Greek mountain Taygetos on health and oxidative stress indicators in healthy individuals. The results of the present investigation will help to elucidate the effects of an extract derived from a plant product on markers of health and oxidative stress in apparently healthy individuals.

Methodology: 30 healthy individuals will be enrolled in the study. Participants will give their informed consent after they will be informed about the purposes, procedures, risks and benefits associated with the study. Participants will be randomly allocated to either a Sideritis spp or a placebo supplementation group and they will consume 1500 mg/day of Sideritis or placebo, distributed in three equal doses (every 8 hours) for one month. At baseline and post-intervention, volunteers will be assessed for their anthropometric profile, muscle function and cardiorespiratory capacity and will provide a resting blood sample for the assessment of oxidative stress and health biomarkers. Participants will be asked to record their diet for 3 days prior to the study and they will be asked to follow the same dietary pattern for 3 days before the post-intervention assessments.

Conditions

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Oxidative Stress Lipidemia

Keywords

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Sideritis Extract Antioxidants Oxidative stress Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sideritis Scardica (SidTea+) extract

Sideritis Scardica (SidTea+) extract will be administered to participants in this arm.

Group Type EXPERIMENTAL

Sideritis Scardica (SidTea+) extract supplementation

Intervention Type DIETARY_SUPPLEMENT

1500 mg of Sideritis Scardica (SidTea+) extract per day, divided into 3 equal doses of 500 mg (every 8 hours) for a total duration of 1 month

Placebo

Placebo will be administered to participants in this arm.

Group Type PLACEBO_COMPARATOR

Placebo supplementation

Intervention Type DIETARY_SUPPLEMENT

1500 mg of placebo per day, divided into 3 equal doses of 500 mg (every 8 hours) for a total duration of 1 month

Interventions

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Sideritis Scardica (SidTea+) extract supplementation

1500 mg of Sideritis Scardica (SidTea+) extract per day, divided into 3 equal doses of 500 mg (every 8 hours) for a total duration of 1 month

Intervention Type DIETARY_SUPPLEMENT

Placebo supplementation

1500 mg of placebo per day, divided into 3 equal doses of 500 mg (every 8 hours) for a total duration of 1 month

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy Individuals aged 18-65 years

Exclusion Criteria

* Musculoskeletal injury
* Dietary supplements
* Medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Athanasios Z. Jamurtas

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Athanasios Z. Jamurtas, Professor

Role: STUDY_DIRECTOR

University of Thessaly

Konstantinos Papanikolaou, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

Locations

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Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly

Trikala, Thessaly, Greece

Site Status

Countries

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Greece

References

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Tsaknis J, Lalas S. Extraction and identification of natural antioxidant from Sideritis euboea (mountain tea). J Agric Food Chem. 2005 Aug 10;53(16):6375-81. doi: 10.1021/jf0479261.

Reference Type BACKGROUND
PMID: 16076121 (View on PubMed)

Gabrieli CN, Kefalas PG, Kokkalou EL. Antioxidant activity of flavonoids from Sideritis raeseri. J Ethnopharmacol. 2005 Jan 15;96(3):423-8. doi: 10.1016/j.jep.2004.09.031. Epub 2004 Nov 6.

Reference Type BACKGROUND
PMID: 15619561 (View on PubMed)

Yao LH, Jiang YM, Shi J, Tomas-Barberan FA, Datta N, Singanusong R, Chen SS. Flavonoids in food and their health benefits. Plant Foods Hum Nutr. 2004 Summer;59(3):113-22. doi: 10.1007/s11130-004-0049-7.

Reference Type BACKGROUND
PMID: 15678717 (View on PubMed)

Other Identifiers

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UTH-DPESS_Sideritis

Identifier Type: -

Identifier Source: org_study_id