NCT02701270已完成不适用
Randomised, Single-blinded, Controlled, Crossover and Acute Clinical Intervention to Assess the Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers
Danisco1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response
研究概览
简要总结
The purpose of this study is to determine whether DuPont Experimental Dietary Fibre products 1 and 2 are digested using glycaemic and insulinaemic response as markers.
详细描述
DuPont Experimental Dietary Fibre products 1 and 2 glycaemic and insulinaemic response will be compared against that of polydextrose and dextrose when given to adult healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
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
- •BMI between 18-27 kg/m
- •Self-diagnosed as healthy at the time of recruitment, confirmed by medical questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders.
- •No blood donations during the study.
- •Reported intense sporting activities < 10hr/w.
- •Reported alcohol consumption ≤21 units/w (female volunteers) or ≤28 units/w (male volunteers).
- •Feasibility to give blood sample as per study protocol.
- •Informed consent signed
排除标准
- •Dislike, allergy or intolerance to test products.
- •Fasting blood glucose levels <4.4 or >6.
- •Volunteer has any health conditions that would prevent him/her from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the Principal Investigator.
- •Volunteer with history of diabetes and high blood pressure.
- •Having consumed anything apart from plain water in the twelve hours prior to the first test day.
- •Volunteer and/or immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the clinical research organization.
- •Reported lactating (or lactating < 6 weeks ago), pregnant (or pregnant < 3 months ago) or wish to become pregnant during the study.
- •Reported participation in another biomedical trial 1 month before the start of the study.
研究组 & 干预措施
Experimental Dietary Fibre 1
Experimental
干预措施: Experimental Dietary Fibre 1 (Dietary Supplement)
Experimental Dietary Fibre 2
Experimental
干预措施: Experimental Dietary Fibre 2 (Dietary Supplement)
Dextrose control
Active Comparator
干预措施: Dextrose (Dietary Supplement)
Polydextrose
Active Comparator
干预措施: Polydextrose (Dietary Supplement)
结局指标
主要结局
Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response
时间窗: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose
次要结局
- Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response(0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose)
研究者
研究点 (1)
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