Effects of a Single Oral Dose of Sweet Protein Sweelin® on Blood Glucose and Insulin Levels in Healthy Adults: a Crossover, Double Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Blood glucose incremental area under the curve (iAUC)
研究概览
简要总结
The study aims to evaluate, for the first time, the post-prandial effects of a single oral administration of Serendipity Berry Sweet Protein sweelin® compared to glucose and stevia, as a commercial sweetener, in healthy adults. The study design is a single center, randomized, crossover study.
Each subject will receive a single oral dose of sweelin® compared with an equivalently sweet dose of glucose and stevia dissolved in a water beverage with flavor.
The advantage of a crossover design is that it will allow to compare the blood glucose and insulin levels of each subject to his baseline in every test beverage, and to remove the inter-subject variability. The post-prandial effects will be monitored with multiple blood sampling up to 120 minutes post dosing.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Age 18-70 years
- •BMI between 18.0 and 33.0 calculated as Weight (Kg)/Height (m2).
- •Stable weight in the last 3 months (+/-5kg).
- •Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
排除标准
- •Pregnant or breastfeeding women.
- •Subjects with a significant allergic response or history of food allergies deemed clinically significant or exclusionary for the study.
- •Diabetes mellitus or use of medications affecting glucose metabolism.
- •Subjects with any gastrointestinal disease which may affect absorption
- •Subjects with any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
- •Subjects which have undergone major surgery in the last 3 months.
- •Subjects who are non-cooperative or unwilling to sign the consent form.
研究组 & 干预措施
Beverage containing Serendipity Berry Sweet Protein
Single dose of 400 ml beverage containing Serendipity Berry Sweet Protein to be consumed in less than 15 minutes. The beverage will be at a similar sweet potency as 75 grams glucose.
干预措施: Sweet Beverage (Other)
Beverage containing glucose
Single dose of 400 ml beverage containing 75 grams glucose to be consumed in less than 15 minutes.
干预措施: Sweet Beverage (Other)
Beverage containing Stevia
Single dose of 400 ml beverage containing Stevia to be consumed in less than 15 minutes. The beverage will be at a similar sweet potency as 75 grams glucose.
干预措施: Sweet Beverage (Other)
结局指标
主要结局
Blood glucose incremental area under the curve (iAUC)
时间窗: 120 minutes after single oral dose administration
To monitor blood glucose incremental area under the curve (iAUC) response of sweelin® in healthy adult subjects, following a single oral administration, in comparison to glucose and stevia.
次要结局
- Insulin incremental area under the curve (iAUC)(120 minutes after single oral dose administration)