25gr. Glucomedics vs 25gr. Zusto

Objective: to compare blood glucose and insulin responses after consumption of 100ml water, sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink)

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Glucomedics®; Dietary supplement: Zusto

Detailed Description

This is an experimental study enrolling 10 healthy female subjects. The study compares the blood glucose and insulin responses after consumption of 100ml water, sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink). Subjects need to be fasted for at least 8 hours before all visits. At visit 1, five women will consume the solution with 25gr Zusto®, the other five will have the solution with 25gr Glucomedics®. On visit 2, groups will be switched. Visit 1 and 2 will be performed within approximately one week interval.

Both drinks will be identical in amount of water and only be different by the use of 25gr Glucomedics® and 25gr Zusto®.

Before intake of the drink, vital signs, weight and bedside blood glucose and baseline blood samples - 15' and 0' for glucose, insulin and C-peptide will be taken at visit 1 and 2. Both drinks will be consumed within 5 minutes and time of start and end of intake of Zusto® / Glucomedics® will be documented.

Blood samples for glucose, insulin and C-peptide will be taken at 15', 30', 60', 90', 120' and 180' after start of intake 25gr Zusto® and 25gr Glucomedics®.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female subjects
• Age between 30 and 50 years
• BMI between 20 and 30 kg/m²

Exclusion Criteria:

• No first degree relatives with mellitus type 1 or type 2
• No intake of medication with influence blood glucose levels
• Pregnant, breast feeding or planning to become pregnant during the study
• Employer of the investigator or study center with direct involvement in the proposed study or other studies under the direction of the investigator or study center

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glucomedics®; 25gr Glucomedics®	Dietary supplement: Glucomedics®; 25gr
Experimental: Zusto®; 25gr Zusto®	Dietary supplement: Zusto; 25gr

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the difference in glycemic index between 25gr. Zusto® and 25gr. Glucomedics®	GI values will be calculated using the iAUC of Zusto® intake and Glucomedics® intake.	1 month

Collaborators and Investigators

• Sponsor: Bart Keymeulen

Publications and helpful links

General Publications

• Pen JJ, Khorosheva G, Van de Velde U, Debroye C, Huyghebaert A, Rottiers R, Keymeulen B. Zusto: A new sweetening agent with low glycemic index. Clin Nutr ESPEN. 2018 Feb;23:103-106. doi: 10.1016/j.clnesp.2017.11.009. Epub 2017 Dec 7.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2015/030