Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

SEGATROM: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition (SEGATROM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02219295
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : March 19, 2015
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

Brief 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.

Condition or disease Intervention/treatment Phase
Disorder of Glucose Regulation Dietary Supplement: sweet block Dietary Supplement: bitter block Dietary Supplement: umami-block Other: gastroscopy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition
Study Start Date : December 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


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
Dietary Supplement: sweet block
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:
  • Sugars as sucrose, glucose, palatinose, galactose
  • artificial sweeteners as saccharin
  • sweet taste antagonist as lactisol

Dietary Supplement: bitter block
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:
  • application of
  • sinigrin
  • lactucopicrin
  • iso-alpha-acid

Dietary Supplement: umami-block
oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
Other Name: application of glutamate and glutamate+IMP,

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)
Dietary Supplement: sweet block
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:
  • Sugars as sucrose, glucose, palatinose, galactose
  • artificial sweeteners as saccharin
  • sweet taste antagonist as lactisol

Dietary Supplement: bitter block
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:
  • application of
  • sinigrin
  • lactucopicrin
  • iso-alpha-acid

Dietary Supplement: umami-block
oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
Other Name: application of glutamate and glutamate+IMP,

Experimental: umami-block

application of glutamate and glutamate +IMP

same procedure as above

Dietary Supplement: sweet block
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:
  • Sugars as sucrose, glucose, palatinose, galactose
  • artificial sweeteners as saccharin
  • sweet taste antagonist as lactisol

Dietary Supplement: bitter block
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:
  • application of
  • sinigrin
  • lactucopicrin
  • iso-alpha-acid

Dietary Supplement: umami-block
oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
Other Name: application of glutamate and glutamate+IMP,

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
Other: gastroscopy
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:
  • tissue samples
  • sweet taste receptor stimualtion
  • artificial sweetener saccharin
  • SGLT-1




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy persons

Exclusion Criteria:

  • Tumor in history
  • Pregnancy
  • Severe illness in history
  • Bodymass index below 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219295


Locations
Layout table for location information
Germany
Department of Clinical Nutrition
Nuthetal, Brandenburg, Germany, D-14558
Sponsors and Collaborators
German Institute of Human Nutrition
Technische Universität München
Investigators
Layout table for investigator information
Principal Investigator: Andreas FH Peiffer, Prof German Institute of Human Nutrition

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Prof. Dr. med. Andreas F. H. Pfeiffer, Prof. Dr. med., German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT02219295     History of Changes
Other Study ID Numbers: BMBF 11005D
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition:
SGLT1 (sodium dependent glucose transporter)
Glut-transporters
taste receptors genes
sweet taste receptor T1R2T1R3
bitter taste receptors of the hTAS2gene family