Sideritis Supplementation, Oxidative Stress and Health

NCT05729659 | Completed

• 1 other identifier: UTH-DPESS_Sideritis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Lipidemia

Keywords

Sideritis; Extract; Antioxidants; Oxidative stress; Health

Outcome Measures

Primary Outcomes (15)

• Change in glutathione concentration

  Glutathione concentration will be analyzed in erythrocytes

  Change from baseline to 1 month

• Change in catalase activity

  Catalase activity will be analyzed in erythrocytes

  Change from baseline to 1 month

• Change in total antioxidant capacity

  Total antioxidant capacity will be analyzed in serum

  Change from baseline to 1 month

• Change in thiobarbituric acid reactive substances concentration

  Thiobarbituric acid reactive substances concentration will be analyzed in plasma

  Change from baseline to 1 month

• Change in protein carbonyls concentration

  Protein carbonyls will be analyzed in plasma

  Change from baseline to 1 month

• Change in glucose concentration

  Glucose concentration will be analyzed in plasma

  Change from baseline to 1 month

• Change in cholesterol concentration

  Cholesterol concentration will be analyzed in plasma

  Change from baseline to 1 month

• Change in triglycerides concentration

  triglycerides concentration will be analyzed in plasma

  Change from baseline to 1 month

• Change in high-density lipoprotein concentration

  High-density lipoprotein concentration will be analyzed in plasma

  Change from baseline to 1 month

• Change in bilirubin concentration

  Bilirubin concentration will be analyzed in plasma

  Change from baseline to 1 month

• Change in lactate dehydrogenase concentration

  Lactate dehydrogenase concentration will be analyzed in plasma

  Change from baseline to 1 month

• Change in serum glutamic-oxaloacetic transaminase concentration

  Serum glutamic-oxaloacetic transaminase will be analyzed in serum

  Change from baseline to 1 month

• Change in gamma-glutamyl transpeptidase concentration

  Gamma-glutamyl transpeptidase concentration will be analyzed in serum

  Change from baseline to 1 month

• Change in creatinine concentration

  Creatinine concentration will be analyzed in serum

  Change from baseline to 1 month

• Change in uric acid concentration

  Uric acid concentration will be analyzed in serum

  Change from baseline to 1 month

Secondary Outcomes (11)

• Change in handgrip strength

  Change from baseline to 1 month

• Change in estimated maximal oxygen consumption (eVO2max)

  Change from baseline to 1 month

• Change in body weight

  Change from baseline to 1 month

• Change in body fat

  Change from baseline to 1 month

• Change in resting heart rate

  Change from baseline to 1 month

Study Arms (2)

Sideritis Scardica (SidTea+) extract

EXPERIMENTAL

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

Dietary Supplement: Sideritis Scardica (SidTea+) extract supplementation

Placebo

PLACEBO COMPARATOR

Placebo will be administered to participants in this arm.

Dietary Supplement: Placebo supplementation

Interventions

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

Sideritis Scardica (SidTea+) extract

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Individuals aged 18-65 years

You may not qualify if:

• Musculoskeletal injury
• Dietary supplements
• Medication

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

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

Trikala, Thessaly, 42150, Greece

Location

Related Publications (3)

• 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.

  PMID: 16076121 BACKGROUND

• 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.

  PMID: 15619561 BACKGROUND

• 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.

  PMID: 15678717 BACKGROUND

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Athanasios Z. Jamurtas, Professor

  University of Thessaly

  STUDY DIRECTOR

• Konstantinos Papanikolaou, PhD

  University of Thessaly

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 15, 2023
• Study Start: February 15, 2023
• Primary Completion: May 25, 2023
• Study Completion: October 1, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)