Innovative Biotechnological Production of Antioxidant Products of Plant Origin From Microbial Factories, and Essential Oils From the Greek Flora, for the Creation of New Quality Health Products and Nutritional Supplements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- oxLDL
研究概览
简要总结
Several natural compounds have been explored as immune-boosting, antioxidant, and anti-inflammatory dietary supplements. Amongst them, hydroxytyrosol a natural antioxidant found in olive products, and endemic medicinal plants have attracted the scientific's community and industry's interest. The safety and biological activity of a standardised supplement containing 10 mg of hydroxytyrosol synthesized using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from oregano vulgaris, sage officinalis and crithmum maritimum in an open-label, single-arm, prospective clinical study were studied. The supplement capsules were given to 12 healthy subjects, aged 26-52, once a day for 8 weeks.
详细描述
The study was designed to evaluate the safety and biological activity of the supplement Antiox-Plus: one capsule/day, 15 minutes before their main meal which contained 10 mg of HT, synthesised using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from Origanum vulgare, Sage officinalis and Crithmum maritimum. The volunteers will consume the supplement for 8 weeks. A follow-up analysis will be performed one month after the end of the supplementation period (12 weeks from the initiation of the study). During this time, the participants will consume a placebo.
The volunteers are instructed to maintain their normal dietary habits. The following measurements will be taken: A) Dietary assessment at the beginning of the study (week 0), B) Body composition analysis at the beginning (week 0) and the end of the study (week 8), C) biochemical and laboratory analysis of plasma samples at week 0, 8 and 12.
The volunteers will record their food intake for 3 days (including one day of the weekend) and will fulfil a food frequency questionnaire. Analysis of their data will be done by a certified nutritionist. Nutritional assessment will be performed using the Evexis dietary software. The Tanita Dual Frequency Body Composition Monitor "Innerscan" will be employed to measure weight, muscle mass, muscle quality score, heart rate, body fat (%), physique rating, visceral fat, metabolic age, basal metabolic rate, bone mass, body water (%) and body mass index (BMI) in the morning. Physical activity will be assessed by the Greek version of the short International Physical Activity Questionnaire (IPAQ-short).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 25 and 65 years
- •the absence of any chronic health conditions
- •adequate understanding of the study
排除标准
- •the presence of any chronic health conditions (diabetes, hypertension, dyslipidemia)
- •intake of nutritional supplements over the past 60 days
- •heavy smokers (≥25 cigarettes/day)
- •high alcohol use (men >14 drinks/week, women >7 drinks/week)
结局指标
主要结局
oxLDL
时间窗: Change from Baseline up to 12 weeks
oxLDL (mU/mL)
Homocysteine
时间窗: Change from Baseline up to 12 weeks
Homocysteine (μmol/L)
Fasting blood glucose
时间窗: Change from Baseline up to 12 weeks
Fasting blood glucose (md/dL)
次要结局
- Catalase(Change from Baseline up to 12 weeks)
- Glutathione(Change from Baseline up to 12 weeks)
- LDL-cholesterol(Change from Baseline up to 12 weeks)
- HDL-cholesterol(Change from Baseline up to 12 weeks)
研究者
Patra Vezyraki
Professor
University of Ioannina