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临床试验/NCT05729659
NCT05729659已完成不适用

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

University of Thessaly2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change in catalase activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy Individuals aged 18-65 years

排除标准

  • Musculoskeletal injury
  • Dietary supplements
  • Medication

结局指标

主要结局

Change in catalase activity

时间窗: Change from baseline to 1 month

Catalase activity will be analyzed in erythrocytes

Change in thiobarbituric acid reactive substances concentration

时间窗: Change from baseline to 1 month

Thiobarbituric acid reactive substances concentration will be analyzed in plasma

Change in cholesterol concentration

时间窗: Change from baseline to 1 month

Cholesterol concentration will be analyzed in plasma

Change in triglycerides concentration

时间窗: Change from baseline to 1 month

triglycerides concentration will be analyzed in plasma

Change in high-density lipoprotein concentration

时间窗: Change from baseline to 1 month

High-density lipoprotein concentration will be analyzed in plasma

Change in bilirubin concentration

时间窗: Change from baseline to 1 month

Bilirubin concentration will be analyzed in plasma

Change in glutathione concentration

时间窗: Change from baseline to 1 month

Glutathione concentration will be analyzed in erythrocytes

Change in total antioxidant capacity

时间窗: Change from baseline to 1 month

Total antioxidant capacity will be analyzed in serum

Change in protein carbonyls concentration

时间窗: Change from baseline to 1 month

Protein carbonyls will be analyzed in plasma

Change in glucose concentration

时间窗: Change from baseline to 1 month

Glucose concentration will be analyzed in plasma

Change in lactate dehydrogenase concentration

时间窗: Change from baseline to 1 month

Lactate dehydrogenase concentration will be analyzed in plasma

Change in serum glutamic-oxaloacetic transaminase concentration

时间窗: Change from baseline to 1 month

Serum glutamic-oxaloacetic transaminase will be analyzed in serum

Change in gamma-glutamyl transpeptidase concentration

时间窗: Change from baseline to 1 month

Gamma-glutamyl transpeptidase concentration will be analyzed in serum

Change in creatinine concentration

时间窗: Change from baseline to 1 month

Creatinine concentration will be analyzed in serum

Change in uric acid concentration

时间窗: Change from baseline to 1 month

Uric acid concentration will be analyzed in serum

次要结局

  • Change in diastolic and systolic blood pressure(Change from baseline to 1 month)
  • 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)
  • Dietary macro-nutrient analysis(Baseline)
  • Change in waist and hip circumference(Change from baseline to 1 month)
  • Change in complete blood count(Change from baseline to 1 month)
  • Dietary micro-nutrient analysis(Baseline)
  • Physical activity level(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Athanasios Z. Jamurtas

Professor

University of Thessaly

研究点 (2)

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