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.
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
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
30
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
1500 mg of placebo per day, divided into 3 equal doses of 500 mg (every 8 hours) for a total duration of 1 month
Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly
Trikala, Thessaly, Greece
Change in glutathione concentration
Glutathione concentration will be analyzed in erythrocytes
Time frame: Change from baseline to 1 month
Change in catalase activity
Catalase activity will be analyzed in erythrocytes
Time frame: Change from baseline to 1 month
Change in total antioxidant capacity
Total antioxidant capacity will be analyzed in serum
Time frame: Change from baseline to 1 month
Change in thiobarbituric acid reactive substances concentration
Thiobarbituric acid reactive substances concentration will be analyzed in plasma
Time frame: Change from baseline to 1 month
Change in protein carbonyls concentration
Protein carbonyls will be analyzed in plasma
Time frame: Change from baseline to 1 month
Change in glucose concentration
Glucose concentration will be analyzed in plasma
Time frame: Change from baseline to 1 month
Change in cholesterol concentration
Cholesterol concentration will be analyzed in plasma
Time frame: Change from baseline to 1 month
Change in triglycerides concentration
triglycerides concentration will be analyzed in plasma
Time frame: Change from baseline to 1 month
Change in high-density lipoprotein concentration
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High-density lipoprotein concentration will be analyzed in plasma
Time frame: Change from baseline to 1 month
Change in bilirubin concentration
Bilirubin concentration will be analyzed in plasma
Time frame: Change from baseline to 1 month
Change in lactate dehydrogenase concentration
Lactate dehydrogenase concentration will be analyzed in plasma
Time frame: Change from baseline to 1 month
Change in serum glutamic-oxaloacetic transaminase concentration
Serum glutamic-oxaloacetic transaminase will be analyzed in serum
Time frame: Change from baseline to 1 month
Change in gamma-glutamyl transpeptidase concentration
Gamma-glutamyl transpeptidase concentration will be analyzed in serum
Time frame: Change from baseline to 1 month
Change in creatinine concentration
Creatinine concentration will be analyzed in serum
Time frame: Change from baseline to 1 month
Change in uric acid concentration
Uric acid concentration will be analyzed in serum
Time frame: Change from baseline to 1 month
Change in handgrip strength
Handgrip strength will be measured using a hand dynamometer
Time frame: Change from baseline to 1 month
Change in estimated maximal oxygen consumption (eVO2max)
eVO2max will be measured using an automated open-circuit spirometer
Time frame: Change from baseline to 1 month
Change in body weight
Body weight will be measured using a digital scale
Time frame: Change from baseline to 1 month
Change in body fat
Body fat will be measured by bioelectrical impedance analysis
Time frame: Change from baseline to 1 month
Change in resting heart rate
Resting heart rate will be measured using a heart rate sensor
Time frame: 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
Time frame: Change from baseline to 1 month
Change in waist and hip circumference
Waist and hip circumference will be assessed using a tape measure
Time frame: 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
Time frame: Change from baseline to 1 month
Dietary macro-nutrient analysis
Protein, carbohydrate and fat dietary intake will be measured using diet recalls (food questionnaires)
Time frame: Baseline
Dietary micro-nutrient analysis
Vitamin C, vitamin E, zinc, methionine and cysteine dietary intake will be analyzed using diet recalls (food questionnaires)
Time frame: Baseline
Physical activity level
Low, moderate and vigorous physical activity will be assessed by questionnaires
Time frame: Baseline