25gr. Glucomedics vs 25gr. Zusto

Diabetes Mellitus Clinical Trial

Official title:

25gr. Glucomedics vs 25gr. Zusto

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607345
• Other study ID #: 2015/030
• Status: Completed
• Phase: N/A
• First received: October 12, 2015
• Last updated: November 16, 2015
• Start date: February 2015
• Est. completion date: April 2015

Study information

• Verified date: November 2015
• Source: AZ-VUB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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)

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• Zusto
25gr
• Glucomedics®
25gr

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bart Keymeulen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No