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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05729659
Other study ID # UTH-DPESS_Sideritis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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