NCT04914416已完成不适用
OxxyneaGS: Single Blinded Randomized Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fytexia
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Acute change in glycemia in response to a meal, by measuring glucose concentration in the blood at different time points
研究概览
简要总结
This study aims to evaluate and select the best combination of polyphenol and white kidney bean ingredients in the acute glycemic modulation after a complete meal by measuring blood glucose and insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Glycemia: 100-125mg/dL
- •Both sexes
- •Overweight BMI range (27-32)
- •Age: 20-50 years old
排除标准
- •Metabolic/Chronical disease
- •Menopausal women
- •Being pregnant, breastfeeding or wanting to have a baby
- •Former obese with a history of yoyo effect
- •Have been involved in a weight loss program in the past 12 months or subjected to weight reduction surgery
- •Having started or quit smoking, having a high alcohol consumption
- •Have in the past been in a long-term antibiotherapy (1 month or more) and/or a regular antibiotherapy in the past 12 months
- •Allergy to olive, artichoke, black currant, grapefruit, grape, white kidney bean, olive, pomegranate.
结局指标
主要结局
Acute change in glycemia in response to a meal, by measuring glucose concentration in the blood at different time points
时间窗: 8 hours
次要结局
- Oxxidative stress variation after a meal, measured by oxidized/reduced glutathione (GSH/GSSG)(8 hours)
- Lipid profile evolution after a meal(8 hours)
- Acute change in insulinemia in response to a meal, by measuring insulin concentration in the blood at different time points(8 hours)
研究者
研究点 (2)
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