Sideritis Supplementation, Oxidative Stress and Health

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05729659
• Other study ID #: UTH-DPESS_Sideritis
• Status: Completed
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: October 1, 2023

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy Individuals aged 18-65 years

Exclusion Criteria:

• Musculoskeletal injury

• Dietary supplements

• Medication

Related Conditions & MeSH terms

• Hyperlipidemias
• Lipidemia
• Oxidative Stress

Intervention

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 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

Locations

Country	Name	City	State
Greece	Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly	Trikala	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glutathione concentration	Glutathione concentration will be analyzed in erythrocytes	Change from baseline to 1 month
Primary	Change in catalase activity	Catalase activity will be analyzed in erythrocytes	Change from baseline to 1 month
Primary	Change in total antioxidant capacity	Total antioxidant capacity will be analyzed in serum	Change from baseline to 1 month
Primary	Change in thiobarbituric acid reactive substances concentration	Thiobarbituric acid reactive substances concentration will be analyzed in plasma	Change from baseline to 1 month
Primary	Change in protein carbonyls concentration	Protein carbonyls will be analyzed in plasma	Change from baseline to 1 month
Primary	Change in glucose concentration	Glucose concentration will be analyzed in plasma	Change from baseline to 1 month
Primary	Change in cholesterol concentration	Cholesterol concentration will be analyzed in plasma	Change from baseline to 1 month
Primary	Change in triglycerides concentration	triglycerides concentration will be analyzed in plasma	Change from baseline to 1 month
Primary	Change in high-density lipoprotein concentration	High-density lipoprotein concentration will be analyzed in plasma	Change from baseline to 1 month
Primary	Change in bilirubin concentration	Bilirubin concentration will be analyzed in plasma	Change from baseline to 1 month
Primary	Change in lactate dehydrogenase concentration	Lactate dehydrogenase concentration will be analyzed in plasma	Change from baseline to 1 month
Primary	Change in serum glutamic-oxaloacetic transaminase concentration	Serum glutamic-oxaloacetic transaminase will be analyzed in serum	Change from baseline to 1 month
Primary	Change in gamma-glutamyl transpeptidase concentration	Gamma-glutamyl transpeptidase concentration will be analyzed in serum	Change from baseline to 1 month
Primary	Change in creatinine concentration	Creatinine concentration will be analyzed in serum	Change from baseline to 1 month
Primary	Change in uric acid concentration	Uric acid concentration will be analyzed in serum	Change from baseline to 1 month
Secondary	Change in handgrip strength	Handgrip strength will be measured using a hand dynamometer	Change from baseline to 1 month
Secondary	Change in estimated maximal oxygen consumption (eVO2max)	eVO2max will be measured using an automated open-circuit spirometer	Change from baseline to 1 month
Secondary	Change in body weight	Body weight will be measured using a digital scale	Change from baseline to 1 month
Secondary	Change in body fat	Body fat will be measured by bioelectrical impedance analysis	Change from baseline to 1 month
Secondary	Change in resting heart rate	Resting heart rate will be measured using a heart rate sensor	Change from baseline to 1 month
Secondary	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
Secondary	Change in waist and hip circumference	Waist and hip circumference will be assessed using a tape measure	Change from baseline to 1 month
Secondary	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
Secondary	Dietary macro-nutrient analysis	Protein, carbohydrate and fat dietary intake will be measured using diet recalls (food questionnaires)	Baseline
Secondary	Dietary micro-nutrient analysis	Vitamin C, vitamin E, zinc, methionine and cysteine dietary intake will be analyzed using diet recalls (food questionnaires)	Baseline
Secondary	Physical activity level	Low, moderate and vigorous physical activity will be assessed by questionnaires	Baseline