DiabetesILIAS-2NCT02487537
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2
A study testing custom-made soft drink in people with Diabetes and Pre-diabetes, run by German Institute of Human Nutrition at 1 site in Germany.
Trial summary
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes. Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Pre-diabetes
- What is being tested?
- custom-made soft drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Jul 2019
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
Who cannot join
- no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Institut for Human Nutrition; Department for Clinical Nutrition
Bergholz-Rehbrücke, Brandenburg, 14458
About this study
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.
Read the detailed description
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment will be based on oral glucose tolerance tests.
- Conditions
- Diabetes, Pre-diabetes
- Being tested
- custom-made soft drink
- Keywords
- incretin release
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom-made soft drinkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Non-sweetened soft drink | Placebo comparator | 4-week-intervention with one liter of custom-made soft drink per day; soft drink does not contain glucose or any kind of sweet tasting substance Receives: Dietary Supplement: custom-made soft drink |
| Sweetened soft drink | Active comparator | 4-week-intervention with one liter of custom-made soft drink per day, soft drinks contains an amount of sweetener, which is isosweet compared to 100 g of sucrose in one liter of beverage Receives: Dietary Supplement: custom-made soft drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in release of GIP
change in fasting state and post-glucose release of GIP between the two interventions
Measured: 4 weeks (cross-over)
change in release of GLP-1
change in fasting state and post-glucose release of GLP-1 between the two interventions
Measured: 4 weeks (cross-over)
change in release of GLP-2
change in fasting state and post-glucose release of GLP-2 between the two interventions
Measured: 4 weeks (cross-over)
change in release of PYY
change in fasting state and post-glucose release of PYY between the two interventions
Measured: 4 weeks (cross-over)
change in release of insulin
change in fasting state and post-glucose release of insulin between the two interventions
Measured: 4 weeks (cross-over)
change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
change in fasting state and post-glucose insulin secretion between the two interventions
Measured: 4 weeks (cross-over)
change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
change in fasting state and post-glucose insulin sensitivity between the two interventions
Measured: 4 weeks (cross-over)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2017
- Study completionJul 2019
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 DiabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487537
- Sponsor's protocol ID
- ILIAS-2
- Acronym
- ILIAS-2
- Status last verified
- Jun 2020
- First submitted
- 23 Mar 2015
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
PubMed 32449201
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2
- ClinicalTrials.gov ID
- NCT02487537
- Acronym / sponsor ID
- ILIAS-2 / ILIAS-2
- Conditions
- Diabetes, Pre-diabetes
- Keywords
- incretin release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 1 Jul 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.
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.
Detailed description
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment will be based on oral glucose tolerance tests.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-sweetened soft drink | Placebo comparator | Dietary Supplement: custom-made soft drink4-week-intervention with one liter of custom-made soft drink per day; soft drink does not contain glucose or any kind of sweet tasting substance |
| Sweetened soft drink | Active comparator | Dietary Supplement: custom-made soft drink4-week-intervention with one liter of custom-made soft drink per day, soft drinks contains an amount of sweetener, which is isosweet compared to 100 g of sucrose in one liter of beverage |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (1 listed)
- no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
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 |
|---|---|---|
| custom-made soft drink | Dietary supplement | Non-sweetened soft drink, Sweetened soft drink |
Primary outcome
change in release of GIP
Time frame: 4 weeks (cross-over)
change in fasting state and post-glucose release of GIP between the two interventions
change in release of GLP-1
Time frame: 4 weeks (cross-over)
change in fasting state and post-glucose release of GLP-1 between the two interventions
change in release of GLP-2
Time frame: 4 weeks (cross-over)
change in fasting state and post-glucose release of GLP-2 between the two interventions
change in release of PYY
Time frame: 4 weeks (cross-over)
change in fasting state and post-glucose release of PYY between the two interventions
change in release of insulin
Time frame: 4 weeks (cross-over)
change in fasting state and post-glucose release of insulin between the two interventions
change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
Time frame: 4 weeks (cross-over)
change in fasting state and post-glucose insulin secretion between the two interventions
change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
Time frame: 4 weeks (cross-over)
change in fasting state and post-glucose insulin sensitivity between the two interventions
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 24 Jun 2020.
- Derived from this study: PubMed 32449201Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing custom-made soft drink in people with Diabetes and Pre-diabetes, run by German Institute of Human Nutrition at 1 site in Germany.
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 1 inclusion and 1 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 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
change in release of GIP (time frame: 4 weeks (cross-over)). The study lists 7 primary outcomes in all. 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 NCT02487537, 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 24 Jun 2020.