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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Healthy Adults

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

Sweet Beverage

Other

A beverage containing different sweet ingredients.

Primary outcomes

Blood glucose incremental area under the curve (iAUC)

Time frame: 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 outcomes

Insulin incremental area under the curve (iAUC)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yael Lifshitz

CONTACT

[email protected]

+972-83733111

Sponsors and collaborators

Lead sponsor

Amai Proteins

Industry

Registry information

Official study title

Effects of a Single Oral Dose of Sweet Protein Sweelin® on Blood Glucose and Insulin Levels in Healthy Adults: a Crossover, Double Blinded Clinical Trial

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 25, 2024
Registry last updated: Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting