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Completed

NCT Number: NCT05729659

Sideritis Supplementation, Oxidative Stress and Health

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly

Trikala, Thessaly, 42150, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Individuals aged 18-65 years

Exclusion criteria

  • Musculoskeletal injury
  • Dietary supplements
  • Medication

Treatment and study plan

Sideritis Scardica (SidTea+) extract supplementation

Dietary Supplement

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

Dietary Supplement

1500 mg of placebo per day, divided into 3 equal doses of 500 mg (every 8 hours) for a total duration of 1 month

Primary outcomes

  1. Change in glutathione concentration

    Time frame: Change from baseline to 1 month

    Glutathione concentration will be analyzed in erythrocytes

  2. Change in catalase activity

    Time frame: Change from baseline to 1 month

    Catalase activity will be analyzed in erythrocytes

  3. Change in total antioxidant capacity

    Time frame: Change from baseline to 1 month

    Total antioxidant capacity will be analyzed in serum

  4. Change in thiobarbituric acid reactive substances concentration

    Time frame: Change from baseline to 1 month

    Thiobarbituric acid reactive substances concentration will be analyzed in plasma

  5. Change in protein carbonyls concentration

    Time frame: Change from baseline to 1 month

    Protein carbonyls will be analyzed in plasma

  6. Change in glucose concentration

    Time frame: Change from baseline to 1 month

    Glucose concentration will be analyzed in plasma

  7. Change in cholesterol concentration

    Time frame: Change from baseline to 1 month

    Cholesterol concentration will be analyzed in plasma

  8. Change in triglycerides concentration

    Time frame: Change from baseline to 1 month

    triglycerides concentration will be analyzed in plasma

  9. Change in high-density lipoprotein concentration

    Time frame: Change from baseline to 1 month

    High-density lipoprotein concentration will be analyzed in plasma

  10. Change in bilirubin concentration

    Time frame: Change from baseline to 1 month

    Bilirubin concentration will be analyzed in plasma

  11. Change in lactate dehydrogenase concentration

    Time frame: Change from baseline to 1 month

    Lactate dehydrogenase concentration will be analyzed in plasma

  12. Change in serum glutamic-oxaloacetic transaminase concentration

    Time frame: Change from baseline to 1 month

    Serum glutamic-oxaloacetic transaminase will be analyzed in serum

  13. Change in gamma-glutamyl transpeptidase concentration

    Time frame: Change from baseline to 1 month

    Gamma-glutamyl transpeptidase concentration will be analyzed in serum

  14. Change in creatinine concentration

    Time frame: Change from baseline to 1 month

    Creatinine concentration will be analyzed in serum

  15. Change in uric acid concentration

    Time frame: Change from baseline to 1 month

    Uric acid concentration will be analyzed in serum

Secondary outcomes

  1. Change in handgrip strength

    Time frame: Change from baseline to 1 month

    Handgrip strength will be measured using a hand dynamometer

  2. Change in estimated maximal oxygen consumption (eVO2max)

    Time frame: Change from baseline to 1 month

    eVO2max will be measured using an automated open-circuit spirometer

  3. Change in body weight

    Time frame: Change from baseline to 1 month

    Body weight will be measured using a digital scale

  4. Change in body fat

    Time frame: Change from baseline to 1 month

    Body fat will be measured by bioelectrical impedance analysis

  5. Change in resting heart rate

    Time frame: Change from baseline to 1 month

    Resting heart rate will be measured using a heart rate sensor

  6. Change in diastolic and systolic blood pressure

    Time frame: Change from baseline to 1 month

    Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer

  7. Change in waist and hip circumference

    Time frame: Change from baseline to 1 month

    Waist and hip circumference will be assessed using a tape measure

  8. Change in complete blood count

    Time frame: 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

  9. Dietary macro-nutrient analysis

    Time frame: Baseline

    Protein, carbohydrate and fat dietary intake will be measured using diet recalls (food questionnaires)

  10. Dietary micro-nutrient analysis

    Time frame: Baseline

    Vitamin C, vitamin E, zinc, methionine and cysteine dietary intake will be analyzed using diet recalls (food questionnaires)

  11. Physical activity level

    Time frame: Baseline

    Low, moderate and vigorous physical activity will be assessed by questionnaires

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2023
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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