NCT05372666已完成不适用
Study of the Glycaemic Index of Breads Made From Flour Naturally Rich in Fibre in Healthy Volunteers
Paulic Meunerie SA2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Glycaemic index
研究概览
简要总结
The project aims to evaluate the glycaemic index of breads from different types of flour. In particular, we aim to understand the glycaemic and insulin responses as well as satiety and sensory profiles of the products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having a Body Mass Index (BMI) between 18.5 and 30 kg/m²
- •Non-smoker for more than three months
- •Having signed the informed consent form
- •Likely to follow the constraints generated by the study (one morning per week for 9 weeks)
- •Social insurance
排除标准
- •Pregnant woman
- •Subject with a known progressive somatic or psychiatric disease
- •Fasting blood glucose greater than 6.1 mmol/L (1.10 g/L), postprandial blood glucose greater than 7.7 mmol/L (1.4 g/L) or known diabetes treated or untreated
- •Hyperinsulinemia or a history of insulinoma
- •HbA1c greater than 7 %
- •History of hypercholesterolemia, hypertension, diabetes or glucose intolerance
- •History of food allergy or digestive pathology likely to affect digestion or absorption
- •Renal failure
- •ASAT or ALAT elevation beyond 1.5 times the upper limit
- •Subject consuming more than three glasses per day of alcohol or suffering from various addictions
- •Weight change of more than 3 kg in the last three months
- •Person participating in another clinical study, or in a period of exclusion from another study
- •Person deprived of liberty or under judicial protection
结局指标
主要结局
Glycaemic index
时间窗: glycemia measured over 120 minutes
percentage area under the curve compared to standard white bread as 100% reference
次要结局
未报告次要终点
研究者
研究点 (2)
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