NCT02607345

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

2 months

First QC Date

October 12, 2015

Last Update Submit

November 16, 2015

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Glucomedics®

ACTIVE COMPARATOR

25gr Glucomedics®

Dietary Supplement: Glucomedics®

Zusto®

EXPERIMENTAL

25gr Zusto®

Dietary Supplement: Zusto

Interventions

ZustoDIETARY_SUPPLEMENT

25gr

Zusto®
Glucomedics®DIETARY_SUPPLEMENT

25gr

Glucomedics®

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29460783DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bart Keymeulen, MD PhD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

October 12, 2015

First Posted

November 18, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 18, 2015

Record last verified: 2015-11