search
Back to results

Sideritis Supplementation, Oxidative Stress and Health

Primary Purpose

Oxidative Stress, Lipidemia

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Sideritis Scardica (SidTea+) extract supplementation
Placebo supplementation
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oxidative Stress focused on measuring Sideritis, Extract, Antioxidants, Oxidative stress, Health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sideritis Scardica (SidTea+) extract

Placebo

Arm Description

Sideritis Scardica (SidTea+) extract will be administered to participants in this arm.

Placebo will be administered to participants in this arm.

Outcomes

Primary Outcome Measures

Change in glutathione concentration
Glutathione concentration will be analyzed in erythrocytes
Change in catalase activity
Catalase activity will be analyzed in erythrocytes
Change in total antioxidant capacity
Total antioxidant capacity will be analyzed in serum
Change in thiobarbituric acid reactive substances concentration
Thiobarbituric acid reactive substances concentration will be analyzed in plasma
Change in protein carbonyls concentration
Protein carbonyls will be analyzed in plasma
Change in glucose concentration
Glucose concentration will be analyzed in plasma
Change in cholesterol concentration
Cholesterol concentration will be analyzed in plasma
Change in triglycerides concentration
triglycerides concentration will be analyzed in plasma
Change in high-density lipoprotein concentration
High-density lipoprotein concentration will be analyzed in plasma
Change in bilirubin concentration
Bilirubin concentration will be analyzed in plasma
Change in lactate dehydrogenase concentration
Lactate dehydrogenase concentration will be analyzed in plasma
Change in serum glutamic-oxaloacetic transaminase concentration
Serum glutamic-oxaloacetic transaminase will be analyzed in serum
Change in gamma-glutamyl transpeptidase concentration
Gamma-glutamyl transpeptidase concentration will be analyzed in serum
Change in creatinine concentration
Creatinine concentration will be analyzed in serum
Change in uric acid concentration
Uric acid concentration will be analyzed in serum

Secondary Outcome Measures

Change in handgrip strength
Handgrip strength will be measured using a hand dynamometer
Change in estimated maximal oxygen consumption (eVO2max)
eVO2max will be measured using an automated open-circuit spirometer
Change in body weight
Body weight will be measured using a digital scale
Change in body fat
Body fat will be measured by bioelectrical impedance analysis
Change in resting heart rate
Resting heart rate will be measured using a heart rate sensor
Change in diastolic and systolic blood pressure
Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer
Change in waist and hip circumference
Waist and hip circumference will be assessed using a tape measure
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
Dietary macro-nutrient analysis
Protein, carbohydrate and fat dietary intake will be measured using diet recalls (food questionnaires)
Dietary micro-nutrient analysis
Vitamin C, vitamin E, zinc, methionine and cysteine dietary intake will be analyzed using diet recalls (food questionnaires)
Physical activity level
Low, moderate and vigorous physical activity will be assessed by questionnaires

Full Information

First Posted
January 16, 2023
Last Updated
October 15, 2023
Sponsor
University of Thessaly
search

1. Study Identification

Unique Protocol Identification Number
NCT05729659
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
October 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the present clinical study is to estimate the efficacy of Sideritis Scardica (SidTea+) extract, derived from the mountainous regions of Thessaly in Greece, 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 (SidTea+) extract supplement from the mountainous regions of Thessaly in Greece 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 participate 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Lipidemia
Keywords
Sideritis, Extract, Antioxidants, Oxidative stress, Health

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sideritis Scardica (SidTea+) extract
Arm Type
Experimental
Arm Description
Sideritis Scardica (SidTea+) extract will be administered to participants in this arm.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered to participants in this arm.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sideritis Scardica (SidTea+) extract supplementation
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplementation
Intervention Description
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 Outcome Measure Information:
Title
Change in glutathione concentration
Description
Glutathione concentration will be analyzed in erythrocytes
Time Frame
Change from baseline to 1 month
Title
Change in catalase activity
Description
Catalase activity will be analyzed in erythrocytes
Time Frame
Change from baseline to 1 month
Title
Change in total antioxidant capacity
Description
Total antioxidant capacity will be analyzed in serum
Time Frame
Change from baseline to 1 month
Title
Change in thiobarbituric acid reactive substances concentration
Description
Thiobarbituric acid reactive substances concentration will be analyzed in plasma
Time Frame
Change from baseline to 1 month
Title
Change in protein carbonyls concentration
Description
Protein carbonyls will be analyzed in plasma
Time Frame
Change from baseline to 1 month
Title
Change in glucose concentration
Description
Glucose concentration will be analyzed in plasma
Time Frame
Change from baseline to 1 month
Title
Change in cholesterol concentration
Description
Cholesterol concentration will be analyzed in plasma
Time Frame
Change from baseline to 1 month
Title
Change in triglycerides concentration
Description
triglycerides concentration will be analyzed in plasma
Time Frame
Change from baseline to 1 month
Title
Change in high-density lipoprotein concentration
Description
High-density lipoprotein concentration will be analyzed in plasma
Time Frame
Change from baseline to 1 month
Title
Change in bilirubin concentration
Description
Bilirubin concentration will be analyzed in plasma
Time Frame
Change from baseline to 1 month
Title
Change in lactate dehydrogenase concentration
Description
Lactate dehydrogenase concentration will be analyzed in plasma
Time Frame
Change from baseline to 1 month
Title
Change in serum glutamic-oxaloacetic transaminase concentration
Description
Serum glutamic-oxaloacetic transaminase will be analyzed in serum
Time Frame
Change from baseline to 1 month
Title
Change in gamma-glutamyl transpeptidase concentration
Description
Gamma-glutamyl transpeptidase concentration will be analyzed in serum
Time Frame
Change from baseline to 1 month
Title
Change in creatinine concentration
Description
Creatinine concentration will be analyzed in serum
Time Frame
Change from baseline to 1 month
Title
Change in uric acid concentration
Description
Uric acid concentration will be analyzed in serum
Time Frame
Change from baseline to 1 month
Secondary Outcome Measure Information:
Title
Change in handgrip strength
Description
Handgrip strength will be measured using a hand dynamometer
Time Frame
Change from baseline to 1 month
Title
Change in estimated maximal oxygen consumption (eVO2max)
Description
eVO2max will be measured using an automated open-circuit spirometer
Time Frame
Change from baseline to 1 month
Title
Change in body weight
Description
Body weight will be measured using a digital scale
Time Frame
Change from baseline to 1 month
Title
Change in body fat
Description
Body fat will be measured by bioelectrical impedance analysis
Time Frame
Change from baseline to 1 month
Title
Change in resting heart rate
Description
Resting heart rate will be measured using a heart rate sensor
Time Frame
Change from baseline to 1 month
Title
Change in diastolic and systolic blood pressure
Description
Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer
Time Frame
Change from baseline to 1 month
Title
Change in waist and hip circumference
Description
Waist and hip circumference will be assessed using a tape measure
Time Frame
Change from baseline to 1 month
Title
Change in complete blood count
Description
White blood cells, lymphocytes, monocytes, granulocytes, red blood cells and platelets will be analyzed in whole blood using an automated blood chemistry analyzer
Time Frame
Change from baseline to 1 month
Title
Dietary macro-nutrient analysis
Description
Protein, carbohydrate and fat dietary intake will be measured using diet recalls (food questionnaires)
Time Frame
Baseline
Title
Dietary micro-nutrient analysis
Description
Vitamin C, vitamin E, zinc, methionine and cysteine dietary intake will be analyzed using diet recalls (food questionnaires)
Time Frame
Baseline
Title
Physical activity level
Description
Low, moderate and vigorous physical activity will be assessed by questionnaires
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Individuals aged 18-65 years Exclusion Criteria: Musculoskeletal injury Dietary supplements Medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanasios Z. Jamurtas, Professor
Organizational Affiliation
University of Thessaly
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Konstantinos Papanikolaou, PhD
Organizational Affiliation
University of Thessaly
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly
City
Trikala
State/Province
Thessaly
ZIP/Postal Code
42150
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16076121
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.
Results Reference
background
PubMed Identifier
15619561
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.
Results Reference
background
PubMed Identifier
15678717
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.
Results Reference
background

Learn more about this trial

Sideritis Supplementation, Oxidative Stress and Health

We'll reach out to this number within 24 hrs