Pre-diabetesILIAS-1NCT02459535
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1
A study testing oral stimulation glucose, oral stimulation saccharin and oral stimulation aspartame in people with Pre-diabetes and 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
- Pre-diabetes, Diabetes
- What is being tested?
- oral stimulation glucose, oral stimulation saccharin and oral stimulation aspartame
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 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
- 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.
However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Furthermore, data on human subjects are sparse and controversial.
The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested.
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.
However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Up to now, no single study has ever compared metabolic responses to different AS in the same subjects. Furthermore, data on human subjects are sparse and controversial. This is partially explained by different methodical approaches such as intragastral/intraduodenal application of AS, rather than conventional oral consumption.
The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested: saccharin, aspartame and sucralose.
- Conditions
- Pre-diabetes, Diabetes
- Being tested
- oral stimulation glucose, oral stimulation saccharin, oral stimulation aspartame, oral stimulation sucralose
- Keywords
- incretin release
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral stimulation glucoseOther
oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion
oral stimulation saccharinOther
oral stimulation aspartameOther
oral stimulation sucraloseOther
| Study group | Role | What they receive |
|---|---|---|
| Glucose only | Active comparator | oral ingestion of 54 g Glucose in 300 ml water at t=0 in fasted state; blood samples over 120 mins Receives: Other: oral stimulation glucose |
| Glucose + Saccharin | Active comparator | oral ingestion of 54 g Glucose + 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins Receives: Other: oral stimulation glucose; Other: oral stimulation saccharin |
| Saccharin only | Active comparator | oral ingestion of 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins Receives: Other: oral stimulation saccharin |
| Glucose + Aspartame | Active comparator | oral ingestion of 54 g Glucose 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins Receives: Other: oral stimulation glucose; Other: oral stimulation aspartame |
| Aspartame only | Active comparator | oral ingestion of 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins Receives: Other: oral stimulation aspartame |
| Glucose + Sucralose | Active comparator | oral ingestion of 54 g Glucose + 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins Receives: Other: oral stimulation glucose; Other: oral stimulation sucralose |
| Sucralose only | Active comparator | oral ingestion of 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins Receives: Other: oral stimulation sucralose |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in GIP release
comparison between all seven interventions
Measured: 120 mins
change in GLP-1 release
comparison between all seven interventions
Measured: 120 mins
change in GLP-2 release
comparison between all seven interventions
Measured: 120 mins
change in PYY release
comparison between all seven interventions
Measured: 120 mins
change in insulin release
comparison between all seven interventions
Measured: 120 mins
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion
comparison between all seven interventions
Measured: 120 mins
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
comparison between all seven interventions
Measured: 120 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 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.
- Other trials for Pre-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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 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
- NCT02459535
- Sponsor's protocol ID
- ILIAS-1
- Acronym
- ILIAS-1
- Status last verified
- Jun 2020
- First submitted
- 23 Mar 2015
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
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 1
- ClinicalTrials.gov ID
- NCT02459535
- Acronym / sponsor ID
- ILIAS-1 / ILIAS-1
- Conditions
- Pre-diabetes, Diabetes
- Keywords
- incretin release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 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
- 2 Jun 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.
However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Furthermore, data on human subjects are sparse and controversial.
The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested.
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.
However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Up to now, no single study has ever compared metabolic responses to different AS in the same subjects. Furthermore, data on human subjects are sparse and controversial. This is partially explained by different methodical approaches such as intragastral/intraduodenal application of AS, rather than conventional oral consumption.
The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested: saccharin, aspartame and sucralose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Glucose only | Active comparator | Other: oral stimulation glucoseoral ingestion of 54 g Glucose in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
| Glucose + Saccharin | Active comparator | Other: oral stimulation glucose, Other: oral stimulation saccharinoral ingestion of 54 g Glucose + 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
| Saccharin only | Active comparator | Other: oral stimulation saccharinoral ingestion of 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
| Glucose + Aspartame | Active comparator | Other: oral stimulation glucose, Other: oral stimulation aspartameoral ingestion of 54 g Glucose 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
| Aspartame only | Active comparator | Other: oral stimulation aspartameoral ingestion of 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
| Glucose + Sucralose | Active comparator | Other: oral stimulation glucose, Other: oral stimulation sucraloseoral ingestion of 54 g Glucose + 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
| Sucralose only | Active comparator | Other: oral stimulation sucraloseoral ingestion of 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins |
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)
- 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 |
|---|---|---|
| oral stimulation glucoseoral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion | Other | Glucose + Aspartame, Glucose + Saccharin, Glucose + Sucralose, Glucose only |
| oral stimulation saccharin | Other | Glucose + Saccharin, Saccharin only |
| oral stimulation aspartame | Other | Aspartame only, Glucose + Aspartame |
| oral stimulation sucralose | Other | Glucose + Sucralose, Sucralose only |
Primary outcome
change in GIP release
Time frame: 120 mins
comparison between all seven interventions
change in GLP-1 release
Time frame: 120 mins
comparison between all seven interventions
change in GLP-2 release
Time frame: 120 mins
comparison between all seven interventions
change in PYY release
Time frame: 120 mins
comparison between all seven interventions
change in insulin release
Time frame: 120 mins
comparison between all seven interventions
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion
Time frame: 120 mins
comparison between all seven interventions
change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
Time frame: 120 mins
comparison between all seven 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.
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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 oral stimulation glucose, oral stimulation saccharin and oral stimulation aspartame in people with Pre-diabetes and 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. 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 GIP release (time frame: 120 mins). 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?
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.