Lipidemia, Oxidative Stress
Conditions
Keywords
Sideritis, Extract, Antioxidants, Oxidative stress, Health
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.
Interventions
DIETARY_SUPPLEMENTSideritis 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
DIETARY_SUPPLEMENTPlacebo 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
Sponsors
University of Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Individuals aged 18-65 years
Exclusion criteria
* Musculoskeletal injury * Dietary supplements * Medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in uric acid concentration | Change from baseline to 1 month | Uric acid concentration will be analyzed in serum |
| 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 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 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 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 glutathione concentration | Change from baseline to 1 month | Glutathione concentration will be analyzed in erythrocytes |
| Change in catalase activity | Change from baseline to 1 month | Catalase activity will be analyzed in erythrocytes |
| Change in total antioxidant capacity | Change from baseline to 1 month | Total antioxidant capacity will be analyzed in serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 macro-nutrient analysis | Baseline | Protein, carbohydrate and fat dietary intake will be measured using diet recalls (food questionnaires) |
| 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 |
| Change in handgrip strength | Change from baseline to 1 month | Handgrip strength will be measured using a hand dynamometer |
Countries
Greece
Outcome results
None listed