Healthy Adults
Conditions
Brief summary
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.
Interventions
OTHERSweet Beverage
A beverage containing different sweet ingredients.
Sponsors
Amai Proteins
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects 2. Age 18-70 years 3. BMI between 18.0 and 33.0 calculated as Weight (Kg)/Height (m2). 4. Stable weight in the last 3 months (+/-5kg). 5. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Exclusion criteria
1. Pregnant or breastfeeding women. 2. Subjects with a significant allergic response or history of food allergies deemed clinically significant or exclusionary for the study. 3. Diabetes mellitus or use of medications affecting glucose metabolism. 4. Subjects with any gastrointestinal disease which may affect absorption 5. 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. 6. Subjects which have undergone major surgery in the last 3 months. 7. Subjects who are non-cooperative or unwilling to sign the consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose incremental area under the curve (iAUC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin incremental area under the curve (iAUC) | 120 minutes after single oral dose administration | To monitor blood insulin incremental area under the curve (iAUC) response of sweelin®, following a single oral administration, in comparison to glucose and stevia. |
Contacts
Primary ContactYael Lifshitz
Outcome results
None listed