Effects of a Single Oral Dose of Sweet Protein Sweelin® on Blood Glucose and Insulin Levels in Healthy Adults

N/ANot Yet RecruitingNCT06520293

Amai Proteins20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Adults

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Blood glucose incremental area under the curve (iAUC)

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.

Time frame: 120 minutes after single oral dose administration

Secondary Outcomes

Insulin incremental area under the curve (iAUC)

To monitor blood insulin incremental area under the curve (iAUC) response of sweelin®, following a single oral administration, in comparison to glucose and stevia.