Status:
NOT_YET_RECRUITING
Effects of a Single Oral Dose of Sweet Protein Sweelin® on Blood Glucose and Insulin Levels in Healthy Adults
Lead Sponsor:
Amai Proteins
Conditions:
Healthy Adults
Eligibility:
All Genders
18-70 years
Phase:
NA
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 sw...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06520293
Start Date
September 1 2024
End Date
February 1 2025
Last Update
July 30 2024
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