- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219295
SEGATROM: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition (SEGATROM)
Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brandenburg
-
Bergholz-Rehbrücke, Brandenburg, Germany, D-14558
- Department of Clinical Nutrition
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy persons
Exclusion Criteria:
- Tumor in history
- Pregnancy
- Severe illness in history
- Bodymass index below 18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sweet -block
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
|
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
Other Names:
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
Other Names:
oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
Other Names:
|
Experimental: bitter block
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)
|
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
Other Names:
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
Other Names:
oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
Other Names:
|
Experimental: umami-block
application of glutamate and glutamate +IMP same procedure as above |
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
Other Names:
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
Other Names:
oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
Other Names:
|
Other: gastroscopy
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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in the signalling cascade of the sweet receptor SGLT1 (sodium tranporter 1), changes of receptor expression
Time Frame: 3 years
|
oral application of sweet tasting substances and antagonists, endoscopic collection of tissue samples, determination of molecular resonses by qRT-PCR and immunohistochemistry
|
3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the Area under the Curve (AUC) for PYY in different bitter tasting substances
Time Frame: 3 years
|
oral application of sinigrin, lactucopicrin and other extracts of vegetables and umami, getting insight into the different bitter receptors
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andreas FH Peiffer, Prof, German Institute of Human Nutrition
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BMBF 11005D
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Disorder of Glucose Regulation
-
PHJ van der VoortAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)CompletedDisorder of Glucose RegulationNetherlands
-
Lund UniversitySwedish Foundation for Strategic ResearchCompleted
-
Lund UniversitySwedish Foundation for Strategic ResearchCompleted
-
Lund UniversitySwedish Foundation for Strategic ResearchCompleted
-
Woman'sMerck Sharp & Dohme LLCCompletedDisorder of Glucose RegulationUnited States
-
Lund UniversityAnti-Diabetic Food CentreCompletedPostprandial Blood Glucose RegulationSweden
-
University of TorontoCompletedGlucose Metabolism | Appetite Regulation | HealthCanada
-
Oslo University HospitalCompletedRegulation of Inflammatory ResponseNorway
-
United States Department of Agriculture (USDA)CompletedSubstrate Oxidation | Glucose Regulation | Substrate AbsorptionUnited States
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); University of California, Davis and other collaboratorsCompletedRegulation of Muscle Protein SynthesisCanada
Clinical Trials on sweet block
-
Temple UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD); Monell...Active, not recruiting
-
Bournemouth UniversityUniversity of BristolCompletedRepeated Sweet Food ConsumptionUnited Kingdom
-
Taipei Medical UniversityCompleted
-
University of California, DavisUC Davis Foods for Health Institute; Mengniu DairyActive, not recruitingMicrobial Colonization | Infant DevelopmentUnited States
-
Taipei Medical UniversityCompleted
-
Bournemouth UniversityUniversity of BristolCompletedRepeated Sweet Food ConsumptionUnited Kingdom
-
Maastricht University Medical CenterCompleted
-
University of California, DavisInternational Centre for Diarrhoeal Disease Research, BangladeshCompleted
-
Northwestern UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingGestational Diabetes | Preventive Care / Anticipatory Guidance | Retention in Care | Postpartum Health | Lifestyle ModificationUnited States