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

June 23, 2020 updated by: Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

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.

Study Overview

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

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Brandenburg
      • Bergholz-Rehbrücke, Brandenburg, Germany, D-14558
        • Department of Clinical Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy persons

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • 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, 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
oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
Other Names:
  • 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)
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
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
oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
Other Names:
  • application of glutamate and glutamate+IMP,
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:
  • 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, 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
oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
Other Names:
  • application of glutamate and glutamate+IMP,
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:
  • tissue samples
  • sweet taste receptor stimualtion
  • artificial sweetener saccharin
  • SGLT-1

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andreas FH Peiffer, Prof, German Institute of Human Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

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.

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