The Effect of Sideritis Scardica (SidTea+) Extract Supplementation on Health and Oxidative Stress Biomarkers in Healthy Individuals
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
- 是
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
Athanasios Z. Jamurtas
Professor
University of Thessaly
