Clinical trial NCT05729659: Sideritis Supplementation, Oxidative Stress and Health
Official title: The Effect of Sideritis Scardica (SidTea+) Extract Supplementation on Health and Oxidative Stress Biomarkers in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Lipidemia
Keywords: Sideritis
Extract
Antioxidants
Oxidative stress
Health
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Healthy Individuals aged 18-65 years

Exclusion Criteria:

* Musculoskeletal injury
* Dietary supplements
* Medication

Primary outcomes:
measure: Change in glutathione concentration
timeFrame: Change from baseline to 1 month
measure: Change in catalase activity
timeFrame: Change from baseline to 1 month
measure: Change in total antioxidant capacity
timeFrame: Change from baseline to 1 month
measure: Change in thiobarbituric acid reactive substances concentration
timeFrame: Change from baseline to 1 month
measure: Change in protein carbonyls concentration
timeFrame: Change from baseline to 1 month
measure: Change in glucose concentration
timeFrame: Change from baseline to 1 month
measure: Change in cholesterol concentration
timeFrame: Change from baseline to 1 month
measure: Change in triglycerides concentration
timeFrame: Change from baseline to 1 month
measure: Change in high-density lipoprotein concentration
timeFrame: Change from baseline to 1 month
measure: Change in bilirubin concentration
timeFrame: Change from baseline to 1 month
measure: Change in lactate dehydrogenase concentration
timeFrame: Change from baseline to 1 month
measure: Change in serum glutamic-oxaloacetic transaminase concentration
timeFrame: Change from baseline to 1 month
measure: Change in gamma-glutamyl transpeptidase concentration
timeFrame: Change from baseline to 1 month
measure: Change in creatinine concentration
timeFrame: Change from baseline to 1 month
measure: Change in uric acid concentration
timeFrame: Change from baseline to 1 month
Secondary outcomes:
measure: Change in handgrip strength
timeFrame: Change from baseline to 1 month
measure: Change in estimated maximal oxygen consumption (eVO2max)
timeFrame: Change from baseline to 1 month
measure: Change in body weight
timeFrame: Change from baseline to 1 month
measure: Change in body fat
timeFrame: Change from baseline to 1 month
measure: Change in resting heart rate
timeFrame: Change from baseline to 1 month
measure: Change in diastolic and systolic blood pressure
timeFrame: Change from baseline to 1 month
measure: Change in waist and hip circumference
timeFrame: Change from baseline to 1 month
measure: Change in complete blood count
timeFrame: Change from baseline to 1 month
measure: Dietary macro-nutrient analysis
timeFrame: Baseline
measure: Dietary micro-nutrient analysis
timeFrame: Baseline
measure: Physical activity level
timeFrame: Baseline
Other outcomes:
Locations:
city: Trikala
country: Greece
facility: Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Athanasios Z. Jamurtas, Professor
role: STUDY_DIRECTOR
affiliation: University of Thessaly
name: Konstantinos Papanikolaou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsaknis J, Lalas S. Extraction and identification of natural antioxidant from Sideritis euboea (mountain tea). J Agric Food Chem. 2005 Aug 10;53(16):6375-81. doi: 10.1021/jf0479261.
citation: Gabrieli CN, Kefalas PG, Kokkalou EL. Antioxidant activity of flavonoids from Sideritis raeseri. J Ethnopharmacol. 2005 Jan 15;96(3):423-8. doi: 10.1016/j.jep.2004.09.031. Epub 2004 Nov 6.
citation: Yao LH, Jiang YM, Shi J, Tomas-Barberan FA, Datta N, Singanusong R, Chen SS. Flavonoids in food and their health benefits. Plant Foods Hum Nutr. 2004 Summer;59(3):113-22. doi: 10.1007/s11130-004-0049-7.