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

Amai Proteins

Status: Not yet enrolling

Conditions: Healthy Adults

Treatments: Other: Sweet Beverage

Study type: Interventional

Funder types: Industry

Identifiers

NCT06520293

SWEELIN01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 3 patient groups

Beverage containing Serendipity Berry Sweet Protein

Experimental group

Description:

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.

Treatment:

Other: Sweet Beverage

Beverage containing glucose

Other group

Description:

Single dose of 400 ml beverage containing 75 grams glucose to be consumed in less than 15 minutes.

Treatment:

Other: Sweet Beverage

Beverage containing Stevia

Other group

Description:

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.

Treatment:

Other: Sweet Beverage