Sideritis Supplementation, Oxidative Stress and Health

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oxidative Stress, Lipidemia

Intervention / Treatment
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* Dietary Supplement: Sideritis Scardica (SidTea+) extract supplementation
* Dietary Supplement: Placebo supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Individuals aged 18-65 years Exclusion Criteria: Musculoskeletal injury Dietary supplements Medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sideritis Scardica (SidTea+) extract<br>Sideritis Scardica (SidTea+) extract will be administered to participants in this arm. | Dietary Supplement: Sideritis Scardica (SidTea+) extract supplementation<br>* 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<br>|
| Placebo Comparator: Placebo<br>Placebo will be administered to participants in this arm. | Dietary Supplement: Placebo supplementation<br>* 1500 mg of placebo per day, divided into 3 equal doses of 500 mg (every 8 hours) for a total duration of 1 month<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sideritis, Extract, Antioxidants, Oxidative stress, Health