Diabetes MellitusNCT02607345
25gr. Glucomedics vs 25gr. Zusto
A study testing Zusto and Glucomedics® in people with Diabetes Mellitus, run by Bart Keymeulen.
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) Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Zusto and Glucomedics®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects
- Age between 30 and 50 years
- BMI between 20 and 30 kg/m²
Who cannot join
- 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
About this study
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)
Read the 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®.
- Conditions
- Diabetes Mellitus
- Being tested
- Zusto, Glucomedics®
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZustoDietary supplement
25gr
Glucomedics®Dietary supplement
25gr
| Study group | Role | What they receive |
|---|---|---|
| Glucomedics® | Active comparator | 25gr Glucomedics® Receives: Dietary Supplement: Glucomedics® |
| Zusto® | Experimental | 25gr Zusto® Receives: Dietary Supplement: Zusto |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bart Keymeulen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bart Keymeulen, Universitair Ziekenhuis Brussel
- Investigators
- Bart Keymeulen, MD PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607345
- Sponsor's protocol ID
- 2015/030
- Status last verified
- Nov 2015
- First submitted
- 12 Oct 2015
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29460783
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 25gr. Glucomedics vs 25gr. Zusto
- ClinicalTrials.gov ID
- NCT02607345
- Acronym / sponsor ID
- 2015/030
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bart KeymeulenUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucomedics® | Active comparator | Dietary Supplement: Glucomedics®25gr Glucomedics® |
| Zusto® | Experimental | Dietary Supplement: Zusto25gr Zusto® |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female subjects
- Age between 30 and 50 years
- BMI between 20 and 30 kg/m²
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zusto25gr | Dietary supplement | Zusto® |
| Glucomedics®25gr | Dietary supplement | Glucomedics® |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Derived from this study: PubMed 29460783Pen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Keymeulen, MD PhD principal investigator
Universitair Ziekenhuis Brussel
Questions about this trial
What is this clinical trial studying?
A study testing Zusto and Glucomedics® in people with Diabetes Mellitus, run by Bart Keymeulen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference in glycemic index between 25gr. Zusto® and 25gr. Glucomedics® (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02607345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.