25gr. Glucomedics vs 25gr. Zusto

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT02607345
• Lead Sponsor: Bart Keymeulen

Brief Summary

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)

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 Timeline

• Study Start: 2015-02
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-10-12
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-16
• Last Update Submitted: 2015-11-16
• Study First Posted: 2015-11-18
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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