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

NCT06520293 | Not Yet Recruiting

• 1 other identifier: SWEELIN01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

  120 minutes after single oral dose administration

Secondary Outcomes (1)

• Insulin incremental area under the curve (iAUC)

  120 minutes after single oral dose administration

Study Arms (3)

Beverage containing Serendipity Berry Sweet Protein

EXPERIMENTAL

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.

Other: Sweet Beverage

Beverage containing glucose

OTHER

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

Other: Sweet Beverage

Beverage containing Stevia

OTHER

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.

Other: Sweet Beverage

Interventions

Sweet Beverage OTHER

A beverage containing different sweet ingredients.

Beverage containing Serendipity Berry Sweet Protein; Beverage containing Stevia; Beverage containing glucose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding women.
• 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.

Sponsors & Collaborators

• Amai Proteins: lead

Study Officials

• David Zeltser, Prof.

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Lifshitz

CONTACT

+972-83733111; yael.lifshitz@amaiproteins.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 25, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: within one year post study completion
• Access Criteria: Interested researchers must submit a formal data access request via email to the sponsor- Amai Proteins yael.lifshitz@amaiproteins.com