Oxidative StressNCT05729659
Sideritis Supplementation, Oxidative Stress and Health
A study testing Sideritis Scardica (SidTea+) extract supplementation in people with Oxidative Stress and Lipidemia, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Lipidemia
- What is being tested?
- Sideritis Scardica (SidTea+) extract supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 15 Feb 2023to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Individuals aged 18-65 years
Who cannot join
- Musculoskeletal injury
- Dietary supplements
- Medication
Trial locations and contacts
1 site in 1 country.
Greece1 site
Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly
Trikala, Thessaly, 42150
About this study
Official title: The Effect of Sideritis Scardica (SidTea+) Extract Supplementation on Health and Oxidative Stress Biomarkers in Healthy Individuals
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.
Read the 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.
- Conditions
- Oxidative Stress, Lipidemia
- Being tested
- Sideritis Scardica (SidTea+) extract supplementation, Placebo supplementation
- Keywords
- Sideritis, Extract, Antioxidants, Oxidative stress, Health
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sideritis Scardica (SidTea+) extract supplementationDietary 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 supplementationDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Sideritis Scardica (SidTea+) extract | Experimental | Sideritis Scardica (SidTea+) extract will be administered to participants in this arm. Receives: Dietary Supplement: Sideritis Scardica (SidTea+) extract supplementation |
| Placebo | Placebo comparator | Placebo will be administered to participants in this arm. Receives: Dietary Supplement: Placebo supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glutathione concentration
Glutathione concentration will be analyzed in erythrocytes
Measured: Change from baseline to 1 month
Change in catalase activity
Catalase activity will be analyzed in erythrocytes
Measured: Change from baseline to 1 month
Change in total antioxidant capacity
Total antioxidant capacity will be analyzed in serum
Measured: Change from baseline to 1 month
Change in thiobarbituric acid reactive substances concentration
Thiobarbituric acid reactive substances concentration will be analyzed in plasma
Measured: Change from baseline to 1 month
Change in protein carbonyls concentration
Protein carbonyls will be analyzed in plasma
Measured: Change from baseline to 1 month
Change in glucose concentration
Glucose concentration will be analyzed in plasma
Measured: Change from baseline to 1 month
Change in cholesterol concentration
Cholesterol concentration will be analyzed in plasma
Measured: Change from baseline to 1 month
Change in triglycerides concentration
triglycerides concentration will be analyzed in plasma
Measured: Change from baseline to 1 month
Change in high-density lipoprotein concentration
High-density lipoprotein concentration will be analyzed in plasma
Measured: Change from baseline to 1 month
Change in bilirubin concentration
Bilirubin concentration will be analyzed in plasma
Measured: Change from baseline to 1 month
Change in lactate dehydrogenase concentration
Lactate dehydrogenase concentration will be analyzed in plasma
Measured: Change from baseline to 1 month
Change in serum glutamic-oxaloacetic transaminase concentration
Serum glutamic-oxaloacetic transaminase will be analyzed in serum
Measured: Change from baseline to 1 month
Change in gamma-glutamyl transpeptidase concentration
Gamma-glutamyl transpeptidase concentration will be analyzed in serum
Measured: Change from baseline to 1 month
Change in creatinine concentration
Creatinine concentration will be analyzed in serum
Measured: Change from baseline to 1 month
Change in uric acid concentration
Uric acid concentration will be analyzed in serum
Measured: Change from baseline to 1 month
Secondary outcomes (11)
Change in handgrip strength
Handgrip strength will be measured using a hand dynamometer
Measured: Change from baseline to 1 month
Change in estimated maximal oxygen consumption (eVO2max)
eVO2max will be measured using an automated open-circuit spirometer
Measured: Change from baseline to 1 month
Change in body weight
Body weight will be measured using a digital scale
Measured: Change from baseline to 1 month
Change in body fat
Body fat will be measured by bioelectrical impedance analysis
Measured: Change from baseline to 1 month
Change in resting heart rate
Resting heart rate will be measured using a heart rate sensor
Measured: 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
Measured: Change from baseline to 1 month
Change in waist and hip circumference
Waist and hip circumference will be assessed using a tape measure
Measured: 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
Measured: Change from baseline to 1 month
Dietary macro-nutrient analysis
Protein, carbohydrate and fat dietary intake will be measured using diet recalls (food questionnaires)
Measured: Baseline
Dietary micro-nutrient analysis
Vitamin C, vitamin E, zinc, methionine and cysteine dietary intake will be analyzed using diet recalls (food questionnaires)
Measured: Baseline
Physical activity level
Low, moderate and vigorous physical activity will be assessed by questionnaires
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start15 Feb 2023
- Primary completion25 May 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios Z. Jamurtas, University of Thessaly
- Investigators
- Athanasios Z. Jamurtas, Professor, Study director, University of ThessalyKonstantinos Papanikolaou, PhD, Principal investigator, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729659
- Sponsor's protocol ID
- UTH-DPESS_Sideritis
- Status last verified
- Dec 2023
- First submitted
- 16 Jan 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16076121Gabrieli 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.
PubMed 15619561Yao 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.
PubMed 15678717
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sideritis Scardica (SidTea+) Extract Supplementation on Health and Oxidative Stress Biomarkers in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05729659
- Acronym / sponsor ID
- UTH-DPESS_Sideritis
- Conditions
- Oxidative Stress, Lipidemia
- Keywords
- Sideritis, Extract, Antioxidants, Oxidative stress, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sideritis Scardica (SidTea+) extract | Experimental | Dietary Supplement: Sideritis Scardica (SidTea+) extract supplementationSideritis Scardica (SidTea+) extract will be administered to participants in this arm. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementationPlacebo will be administered to participants in this arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Individuals aged 18-65 years
Key exclusion criteria (3 listed)
- Musculoskeletal injury
- Dietary supplements
- Medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sideritis Scardica (SidTea+) extract supplementation1500 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 supplement | Sideritis Scardica (SidTea+) extract |
| Placebo supplementation1500 mg of placebo per day, divided into 3 equal doses of 500 mg (every 8 hours) for a total duration of 1 month | Dietary supplement | Placebo |
Primary outcome
Change in glutathione concentration
Time frame: Change from baseline to 1 month
Glutathione concentration will be analyzed in erythrocytes
Change in catalase activity
Time frame: Change from baseline to 1 month
Catalase activity will be analyzed in erythrocytes
Change in total antioxidant capacity
Time frame: Change from baseline to 1 month
Total antioxidant capacity will be analyzed in serum
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
Change in protein carbonyls concentration
Time frame: Change from baseline to 1 month
Protein carbonyls will be analyzed in plasma
Change in glucose concentration
Time frame: Change from baseline to 1 month
Glucose concentration will be analyzed in plasma
Change in cholesterol concentration
Time frame: Change from baseline to 1 month
Cholesterol concentration will be analyzed in plasma
Change in triglycerides concentration
Time frame: Change from baseline to 1 month
triglycerides concentration will be analyzed in plasma
Change in high-density lipoprotein concentration
Time frame: Change from baseline to 1 month
High-density lipoprotein concentration will be analyzed in plasma
Change in bilirubin concentration
Time frame: Change from baseline to 1 month
Bilirubin concentration will be analyzed in plasma
Change in lactate dehydrogenase concentration
Time frame: Change from baseline to 1 month
Lactate dehydrogenase concentration will be analyzed in plasma
Change in serum glutamic-oxaloacetic transaminase concentration
Time frame: Change from baseline to 1 month
Serum glutamic-oxaloacetic transaminase will be analyzed in serum
Change in gamma-glutamyl transpeptidase concentration
Time frame: Change from baseline to 1 month
Gamma-glutamyl transpeptidase concentration will be analyzed in serum
Change in creatinine concentration
Time frame: Change from baseline to 1 month
Creatinine concentration will be analyzed in serum
Change in uric acid concentration
Time frame: Change from baseline to 1 month
Uric acid concentration will be analyzed in serum
11 secondary outcomes
Change in handgrip strength
Time frame: Change from baseline to 1 month
Change in estimated maximal oxygen consumption (eVO2max)
Time frame: Change from baseline to 1 month
Change in body weight
Time frame: Change from baseline to 1 month
Change in body fat
Time frame: Change from baseline to 1 month
Change in resting heart rate
Time frame: Change from baseline to 1 month
Change in diastolic and systolic blood pressure
Time frame: Change from baseline to 1 month
Change in waist and hip circumference
Time frame: Change from baseline to 1 month
Change in complete blood count
Time frame: Change from baseline to 1 month
Dietary macro-nutrient analysis
Time frame: Baseline
Dietary micro-nutrient analysis
Time frame: Baseline
Physical activity level
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 16076121Tsaknis 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.
- Background: PubMed 15619561Gabrieli 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.
- Background: PubMed 15678717Yao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Z. Jamurtas, Professor study director
University of Thessaly
Konstantinos Papanikolaou, PhD principal investigator
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sideritis Scardica (SidTea+) extract supplementation in people with Oxidative Stress and Lipidemia, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glutathione concentration (time frame: Change from baseline to 1 month). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729659, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.