Sideritis Supplementation, Oxidative Stress and Health

The Effect of Sideritis Scardica (SidTea+) Extract Supplementation on Health and Oxidative Stress Biomarkers in Healthy Individuals

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.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Lipidemia
• Intervention / Treatment: Dietary supplement: Sideritis Scardica (SidTea+) extract supplementation; Dietary supplement: Placebo supplementation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaly
    • Trikala, Thessaly, Greece, 42150
      • Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy Individuals aged 18-65 years

Exclusion Criteria:

• Musculoskeletal injury
• Dietary supplements
• Medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sideritis Scardica (SidTea+) extract; Sideritis Scardica (SidTea+) extract will be administered to participants in this arm.	Dietary supplement: 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
Placebo Comparator: Placebo; Placebo will be administered to participants in this arm.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glutathione concentration	Glutathione concentration will be analyzed in erythrocytes	Change from baseline to 1 month
Change in catalase activity	Catalase activity will be analyzed in erythrocytes	Change from baseline to 1 month
Change in total antioxidant capacity	Total antioxidant capacity will be analyzed in serum	Change from baseline to 1 month
Change in thiobarbituric acid reactive substances concentration	Thiobarbituric acid reactive substances concentration will be analyzed in plasma	Change from baseline to 1 month
Change in protein carbonyls concentration	Protein carbonyls will be analyzed in plasma	Change from baseline to 1 month
Change in glucose concentration	Glucose concentration will be analyzed in plasma	Change from baseline to 1 month
Change in cholesterol concentration	Cholesterol concentration will be analyzed in plasma	Change from baseline to 1 month
Change in triglycerides concentration	triglycerides concentration will be analyzed in plasma	Change from baseline to 1 month
Change in high-density lipoprotein concentration	High-density lipoprotein concentration will be analyzed in plasma	Change from baseline to 1 month
Change in bilirubin concentration	Bilirubin concentration will be analyzed in plasma	Change from baseline to 1 month
Change in lactate dehydrogenase concentration	Lactate dehydrogenase concentration will be analyzed in plasma	Change from baseline to 1 month
Change in serum glutamic-oxaloacetic transaminase concentration	Serum glutamic-oxaloacetic transaminase will be analyzed in serum	Change from baseline to 1 month
Change in gamma-glutamyl transpeptidase concentration	Gamma-glutamyl transpeptidase concentration will be analyzed in serum	Change from baseline to 1 month
Change in creatinine concentration	Creatinine concentration will be analyzed in serum	Change from baseline to 1 month
Change in uric acid concentration	Uric acid concentration will be analyzed in serum	Change from baseline to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in handgrip strength	Handgrip strength will be measured using a hand dynamometer	Change from baseline to 1 month
Change in estimated maximal oxygen consumption (eVO2max)	eVO2max will be measured using an automated open-circuit spirometer	Change from baseline to 1 month
Change in body weight	Body weight will be measured using a digital scale	Change from baseline to 1 month
Change in body fat	Body fat will be measured by bioelectrical impedance analysis	Change from baseline to 1 month
Change in resting heart rate	Resting heart rate will be measured using a heart rate sensor	Change from baseline to 1 month
Change in diastolic and systolic blood pressure	Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer	Change from baseline to 1 month
Change in waist and hip circumference	Waist and hip circumference will be assessed using a tape measure	Change from baseline to 1 month
Change in complete blood count	White blood cells, lymphocytes, monocytes, granulocytes, red blood cells and platelets will be analyzed in whole blood using an automated blood chemistry analyzer	Change from baseline to 1 month
Dietary macro-nutrient analysis	Protein, carbohydrate and fat dietary intake will be measured using diet recalls (food questionnaires)	Baseline
Dietary micro-nutrient analysis	Vitamin C, vitamin E, zinc, methionine and cysteine dietary intake will be analyzed using diet recalls (food questionnaires)	Baseline
Physical activity level	Low, moderate and vigorous physical activity will be assessed by questionnaires	Baseline

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Study Director: Athanasios Z. Jamurtas, Professor, University of Thessaly; Principal Investigator: Konstantinos Papanikolaou, PhD, University of Thessaly

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Antioxidants; Oxidative stress; Health; Extract; Sideritis
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: UTH-DPESS_Sideritis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No