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

NCT ID: NCT06520293

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-02-28

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.

Conditions

Healthy Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sweet Beverage

Intervention Type: OTHER

A beverage containing different sweet ingredients.

Beverage containing glucose

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

Group Type: OTHER

Sweet Beverage

Intervention Type: OTHER

A beverage containing different sweet ingredients.

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.

Group Type: OTHER

Sweet Beverage

Intervention Type: OTHER

A beverage containing different sweet ingredients.

Interventions

Sweet Beverage

A beverage containing different sweet ingredients.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amai Proteins

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Zeltser, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Central Contacts

Yael Lifshitz

Role: CONTACT

yael.lifshitz@amaiproteins.com

+972-83733111

Other Identifiers

SWEELIN01

Identifier Type: -

Identifier Source: org_study_id