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25gr. Glucomedics vs 25gr. Zusto

NCT ID: NCT02607345

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-04-30

Brief Summary

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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

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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®.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Glucomedics®

25gr Glucomedics®

Group Type ACTIVE_COMPARATOR

Glucomedics®

Intervention Type DIETARY_SUPPLEMENT

25gr

Zusto®

25gr Zusto®

Group Type EXPERIMENTAL

Zusto

Intervention Type DIETARY_SUPPLEMENT

25gr

Interventions

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Zusto

25gr

Intervention Type DIETARY_SUPPLEMENT

Glucomedics®

25gr

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bart Keymeulen

OTHER

Sponsor Role lead

Responsible Party

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Bart Keymeulen

MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bart Keymeulen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

References

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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.

Reference Type DERIVED
PMID: 29460783 (View on PubMed)

Other Identifiers

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2015/030

Identifier Type: -

Identifier Source: org_study_id