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OpenTrials
Completed

NCT Number: NCT02607345

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)

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Key information

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zusto

Dietary Supplement

25gr

Glucomedics®

Dietary Supplement

25gr

Primary outcomes

  1. the difference in glycemic index between 25gr. Zusto® and 25gr. Glucomedics®

    Time frame: 1 month

    GI values will be calculated using the iAUC of Zusto® intake and Glucomedics® intake.

Sponsors and collaborators

Lead sponsor

Bart Keymeulen

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2015
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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