Disorder of Glucose RegulationSEGATROMNCT02219295
SEGATROM: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition
A study testing sweet block, bitter block and umami-block in people with Disorder of Glucose Regulation, run by German Institute of Human Nutrition at 1 site in Germany.
Trial summary
We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism. There ist growing evidence, that components of the taste signalling system, including the taste receptor proteins , have important functions in the regulation of metabolic parameters in non-gustatory tissues. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Glucose Regulation
- What is being tested?
- sweet block, bitter block and umami-block
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Sep 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy persons
Who cannot join
- Tumor in history
- Pregnancy
- Severe illness in history
- Bodymass index below 18
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Nutrition
Bergholz-Rehbrücke, Brandenburg, D-14558
About this study
Official title: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition
We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism. There ist growing evidence, that components of the taste signalling system, including the taste receptor proteins , have important functions in the regulation of metabolic parameters in non-gustatory tissues.
Read the detailed description
We apply different sweet, bitter and umami taste compounds in a single dose in the human intervention. We use substances as for instance glucose, sucrose,saccharin and lactisol in the sweet part, and substances from cabbage, beer or red endive in the bitter part. For umami we take glutamate.
Blood samples are collected at baseline and 6 times thereafter up to 3hours, to analyse the incretins GLP-1(glucagon-like peptide 1) and GIP(gastrointestinal polypeptide) and other peptide hormones as insulin and PYY(peptide tyrosin trosin) in human beings.
Gastrointestinal mucosa is taken by gastroscopy from the lower duodenum from study subjects for analysis for the presence or absence of functional taste receptors in gastrointestinal tissues.
- Conditions
- Disorder of Glucose Regulation
- Being tested
- sweet block, bitter block, umami-block, gastroscopy
- Keywords
- SGLT1 (sodium dependent glucose transporter), Glut-transporters, taste receptors genes, sweet taste receptor T1R2T1R3, bitter taste receptors of the hTAS2gene family
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sweet blockDietary supplement
Also called Sugars as sucrose, glucose, palatinose, galactose, artificial sweeteners as saccharin, sweet taste antagonist as lactisol
oral application of the above mentioned substances in 300 ml tap water in 5 min. , collection of blood at 0,15,30, 60 ,120,180 minutes for measurement of incretins GIP(gastrointestinal polypeptide) and GLP-1 (glucagon like peptide 1), Protein hormones PYY(Peptide YY),CCK (cholecystokinin), Leptin and Insulin
bitter blockDietary supplement
Also called application of, sinigrin, lactucopicrin, iso-alpha-acid
oral application of the above mentioned substances in 300 ml tap water, collection of blood samples at -15,0,15,30,60,120,180 min for Insulin, GIP,GLP-1, PYY and glucose
umami-blockDietary supplement
Also called application of glutamate and glutamate+IMP,
oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
gastroscopyOther
Also called tissue samples, sweet taste receptor stimualtion, artificial sweetener saccharin, SGLT-1
gastroscopy with and without oral application of saccharin, tissue samples from th upper duodenum by endoscopy for the detection of taste receptor cells in the upper bowel
| Study group | Role | What they receive |
|---|---|---|
| sweet -block | Experimental | application of different sugars, artificial sweeteners and sweet-taste antagonists in a single dose in 300 ml tap water every week up to 7 times and collection of blood samples over 3 hours Receives: Dietary Supplement: sweet block; Dietary Supplement: bitter block; Dietary Supplement: umami-block |
| bitter block | Experimental | application of purified bitter tasting ingredients of vegetables and hop in 300 ml tap water , collection of blood samples for 3h (-15,0,15,30,60,120,180 min) Receives: Dietary Supplement: sweet block; Dietary Supplement: bitter block; Dietary Supplement: umami-block |
| umami-block | Experimental | application of glutamate and glutamate +IMP
same procedure as above Receives: Dietary Supplement: sweet block; Dietary Supplement: bitter block; Dietary Supplement: umami-block |
| gastroscopy | Other | gastroscopy with and without oral intervention with artificial sweetener saccharin to take tissue samples from the upper bowel for the investigation of taste receptor cells in the upper bowel in human beings Receives: Other: gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC): changes of expression levels of the sweet , bitter und umami taste receptors in humans in the upper bowel and responses of incretins to receptor agonists and antagonists
measurement of incretins (GIP, GLP-1) and peptide hormones in human plasma after consumption of different sugars , sweeteners , bitter tasting ingredients of vegetables und umami. Measurement of expression levels in human intestinal mucosa before and after receptor stimulation
Measured: three years
Secondary outcomes (1)
changes in the signalling cascade of the sweet receptor SGLT1 (sodium tranporter 1), changes of receptor expression
oral application of sweet tasting substances and antagonists, endoscopic collection of tissue samples, determination of molecular resonses by qRT-PCR and immunohistochemistry
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startDec 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disorder of Glucose RegulationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
- Investigators
- Andreas FH Peiffer, Prof, Principal investigator, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219295
- Sponsor's protocol ID
- BMBF 11005D
- Acronym
- SEGATROM
- Status last verified
- Jun 2020
- First submitted
- 1 Aug 2014
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang J, Schafer SM, Kabisch S, Csanalosi M, Schuppelius B, Kemper M, Markova M, Meyer NMT, Pivovarova-Ramich O, Keyhani-Nejad F, Rohn S, Pfeiffer AFH. Implication of sugar, protein and incretins in excessive glucagon secretion in type 2 diabetes after mixed meals. Clin Nutr. 2023 Apr;42(4):467-476. doi: 10.1016/j.clnu.2023.02.011. Epub 2023 Feb 21.
PubMed 36857956Keyhani-Nejad F, Kemper M, Schueler R, Pivovarova O, Rudovich N, Pfeiffer AF. Effects of Palatinose and Sucrose Intake on Glucose Metabolism and Incretin Secretion in Subjects With Type 2 Diabetes. Diabetes Care. 2016 Mar;39(3):e38-9. doi: 10.2337/dc15-1891. Epub 2015 Dec 30. No abstract available.
PubMed 26721819
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
- Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition
- ClinicalTrials.gov ID
- NCT02219295
- Acronym / sponsor ID
- SEGATROM / BMBF 11005D
- Conditions
- Disorder of Glucose Regulation
- Keywords
- SGLT1 (sodium dependent glucose transporter), Glut-transporters, taste receptors genes, sweet taste receptor T1R2T1R3, bitter taste receptors of the hTAS2gene family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- Technical University of Munich
- Study start
- Dec 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Aug 2014 (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.
We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism. There ist growing evidence, that components of the taste signalling system, including the taste receptor proteins , have important functions in the regulation of metabolic parameters in non-gustatory tissues.
Detailed description
We apply different sweet, bitter and umami taste compounds in a single dose in the human intervention. We use substances as for instance glucose, sucrose,saccharin and lactisol in the sweet part, and substances from cabbage, beer or red endive in the bitter part. For umami we take glutamate.
Blood samples are collected at baseline and 6 times thereafter up to 3hours, to analyse the incretins GLP-1(glucagon-like peptide 1) and GIP(gastrointestinal polypeptide) and other peptide hormones as insulin and PYY(peptide tyrosin trosin) in human beings.
Gastrointestinal mucosa is taken by gastroscopy from the lower duodenum from study subjects for analysis for the presence or absence of functional taste receptors in gastrointestinal tissues.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sweet -block | Experimental | Dietary Supplement: sweet block, Dietary Supplement: bitter block, Dietary Supplement: umami-blockapplication of different sugars, artificial sweeteners and sweet-taste antagonists in a single dose in 300 ml tap water every week up to 7 times and collection of blood samples over 3 hours |
| bitter block | Experimental | Dietary Supplement: sweet block, Dietary Supplement: bitter block, Dietary Supplement: umami-blockapplication of purified bitter tasting ingredients of vegetables and hop in 300 ml tap water , collection of blood samples for 3h (-15,0,15,30,60,120,180 min) |
| umami-block | Experimental | Dietary Supplement: sweet block, Dietary Supplement: bitter block, Dietary Supplement: umami-blockapplication of glutamate and glutamate +IMP same procedure as above |
| gastroscopy | Other | Other: gastroscopygastroscopy with and without oral intervention with artificial sweetener saccharin to take tissue samples from the upper bowel for the investigation of taste receptor cells in the upper bowel in human beings |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy persons
Key exclusion criteria (4 listed)
- Tumor in history
- Pregnancy
- Severe illness in history
- Bodymass index below 18
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 |
|---|---|---|
| sweet blockAlso: Sugars as sucrose, glucose, palatinose, galactose, artificial sweeteners as saccharin, sweet taste antagonist as lactisoloral application of the above mentioned substances in 300 ml tap water in 5 min. , collection of blood at 0,15,30, 60 ,120,180 minutes for measurement of incretins GIP(gastrointestinal polypeptide) and GLP-1 (glucagon like peptide 1), Protein hormones PYY(Peptide YY),CCK (cholecystokinin), Leptin and Insulin | Dietary supplement | bitter block, sweet -block, umami-block |
| bitter blockAlso: application of, sinigrin, lactucopicrin, iso-alpha-acidoral application of the above mentioned substances in 300 ml tap water, collection of blood samples at -15,0,15,30,60,120,180 min for Insulin, GIP,GLP-1, PYY and glucose | Dietary supplement | bitter block, sweet -block, umami-block |
| umami-blockAlso: application of glutamate and glutamate+IMP,oral application of umami substances as glutamate with and without IMP, collection of blood samples as above | Dietary supplement | bitter block, sweet -block, umami-block |
| gastroscopyAlso: tissue samples, sweet taste receptor stimualtion, artificial sweetener saccharin, SGLT-1gastroscopy with and without oral application of saccharin, tissue samples from th upper duodenum by endoscopy for the detection of taste receptor cells in the upper bowel | Other | gastroscopy |
Primary outcome
Area under the curve (AUC): changes of expression levels of the sweet , bitter und umami taste receptors in humans in the upper bowel and responses of incretins to receptor agonists and antagonists
Time frame: three years
measurement of incretins (GIP, GLP-1) and peptide hormones in human plasma after consumption of different sugars , sweeteners , bitter tasting ingredients of vegetables und umami. Measurement of expression levels in human intestinal mucosa before and after receptor stimulation
1 secondary outcome
changes in the signalling cascade of the sweet receptor SGLT1 (sodium tranporter 1), changes of receptor expression
Time frame: 3 years
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 36857956Zhang J, Schafer SM, Kabisch S, Csanalosi M, Schuppelius B, Kemper M, Markova M, Meyer NMT, Pivovarova-Ramich O, Keyhani-Nejad F, Rohn S, Pfeiffer AFH. Implication of sugar, protein and incretins in excessive glucagon secretion in type 2 diabetes after mixed meals. Clin Nutr. 2023 Apr;42(4):467-476. doi: 10.1016/j.clnu.2023.02.011. Epub 2023 Feb 21.
- Derived from this study: PubMed 26721819Keyhani-Nejad F, Kemper M, Schueler R, Pivovarova O, Rudovich N, Pfeiffer AF. Effects of Palatinose and Sucrose Intake on Glucose Metabolism and Incretin Secretion in Subjects With Type 2 Diabetes. Diabetes Care. 2016 Mar;39(3):e38-9. doi: 10.2337/dc15-1891. Epub 2015 Dec 30. No abstract available.
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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.
Andreas FH Peiffer, Prof principal investigator
German Institute of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sweet block, bitter block and umami-block in people with Disorder of Glucose Regulation, 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 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 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?
Area under the curve (AUC): changes of expression levels of the sweet , bitter und umami taste receptors in humans in the upper bowel and responses of incretins to receptor agonists and antagonists (time frame: three years). 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 NCT02219295, which also lists 2 linked publications.
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.