Sideritis Supplementation, Oxidative Stress and Health
- Conditions
- Oxidative StressLipidemia
- Interventions
- Dietary Supplement: Placebo supplementationDietary Supplement: Sideritis Scardica (SidTea+) extract supplementation
- Registration Number
- NCT05729659
- Lead Sponsor
- University of Thessaly
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Healthy Individuals aged 18-65 years
- Musculoskeletal injury
- Dietary supplements
- Medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo supplementation Placebo will be administered to participants in this arm. Sideritis Scardica (SidTea+) extract Sideritis Scardica (SidTea+) extract supplementation Sideritis Scardica (SidTea+) extract will be administered to participants in this arm.
- Primary Outcome Measures
Name Time Method Change in catalase activity Change from baseline to 1 month Catalase activity will be analyzed in erythrocytes
Change in thiobarbituric acid reactive substances concentration Change from baseline to 1 month Thiobarbituric acid reactive substances concentration will be analyzed in plasma
Change in cholesterol concentration Change from baseline to 1 month Cholesterol concentration will be analyzed in plasma
Change in triglycerides concentration Change from baseline to 1 month triglycerides concentration will be analyzed in plasma
Change in high-density lipoprotein concentration Change from baseline to 1 month High-density lipoprotein concentration will be analyzed in plasma
Change in bilirubin concentration Change from baseline to 1 month Bilirubin concentration will be analyzed in plasma
Change in glutathione concentration Change from baseline to 1 month Glutathione concentration will be analyzed in erythrocytes
Change in total antioxidant capacity Change from baseline to 1 month Total antioxidant capacity will be analyzed in serum
Change in protein carbonyls concentration Change from baseline to 1 month Protein carbonyls will be analyzed in plasma
Change in glucose concentration Change from baseline to 1 month Glucose concentration will be analyzed in plasma
Change in lactate dehydrogenase concentration Change from baseline to 1 month Lactate dehydrogenase concentration will be analyzed in plasma
Change in serum glutamic-oxaloacetic transaminase concentration Change from baseline to 1 month Serum glutamic-oxaloacetic transaminase will be analyzed in serum
Change in gamma-glutamyl transpeptidase concentration Change from baseline to 1 month Gamma-glutamyl transpeptidase concentration will be analyzed in serum
Change in creatinine concentration Change from baseline to 1 month Creatinine concentration will be analyzed in serum
Change in uric acid concentration Change from baseline to 1 month Uric acid concentration will be analyzed in serum
- Secondary Outcome Measures
Name Time Method Change in diastolic and systolic blood pressure Change from baseline to 1 month Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer
Change in handgrip strength Change from baseline to 1 month Handgrip strength will be measured using a hand dynamometer
Change in estimated maximal oxygen consumption (eVO2max) Change from baseline to 1 month eVO2max will be measured using an automated open-circuit spirometer
Change in body weight Change from baseline to 1 month Body weight will be measured using a digital scale
Change in body fat Change from baseline to 1 month Body fat will be measured by bioelectrical impedance analysis
Change in resting heart rate Change from baseline to 1 month Resting heart rate will be measured using a heart rate sensor
Dietary macro-nutrient analysis Baseline Protein, carbohydrate and fat dietary intake will be measured using diet recalls (food questionnaires)
Change in waist and hip circumference Change from baseline to 1 month Waist and hip circumference will be assessed using a tape measure
Change in complete blood count Change from baseline to 1 month White blood cells, lymphocytes, monocytes, granulocytes, red blood cells and platelets will be analyzed in whole blood using an automated blood chemistry analyzer
Dietary micro-nutrient analysis Baseline Vitamin C, vitamin E, zinc, methionine and cysteine dietary intake will be analyzed using diet recalls (food questionnaires)
Physical activity level Baseline Low, moderate and vigorous physical activity will be assessed by questionnaires
Trial Locations
- Locations (1)
Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly
🇬🇷Trikala, Thessaly, Greece