NCT02219295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

2.8 years

First QC Date

August 1, 2014

Last Update Submit

June 23, 2020

Conditions

Keywords

SGLT1 (sodium dependent glucose transporter)Glut-transporterstaste receptors genessweet taste receptor T1R2T1R3bitter taste receptors of the hTAS2gene family

Outcome Measures

Primary Outcomes (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

    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 Outcomes (1)

  • changes in the signalling cascade of the sweet receptor SGLT1 (sodium tranporter 1), changes of receptor expression

    3 years

Other Outcomes (1)

  • Changes in the Area under the Curve (AUC) for PYY in different bitter tasting substances

    3 years

Study Arms (4)

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

Dietary Supplement: sweet blockDietary Supplement: bitter blockDietary 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)

Dietary Supplement: sweet blockDietary Supplement: bitter blockDietary Supplement: umami-block

umami-block

EXPERIMENTAL

application of glutamate and glutamate +IMP same procedure as above

Dietary Supplement: sweet blockDietary Supplement: bitter blockDietary 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

Other: gastroscopy

Interventions

sweet blockDIETARY_SUPPLEMENT

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

Also known as: Sugars as sucrose, glucose, palatinose, galactose, artificial sweeteners as saccharin, sweet taste antagonist as lactisol
bitter blocksweet -blockumami-block
bitter blockDIETARY_SUPPLEMENT

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

Also known as: application of, sinigrin, lactucopicrin, iso-alpha-acid
bitter blocksweet -blockumami-block
umami-blockDIETARY_SUPPLEMENT

oral application of umami substances as glutamate with and without IMP, collection of blood samples as above

Also known as: application of glutamate and glutamate+IMP,
bitter blocksweet -blockumami-block

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

Also known as: tissue samples, sweet taste receptor stimualtion, artificial sweetener saccharin, SGLT-1
gastroscopy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy persons

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Nutrition

Bergholz-Rehbrücke, Brandenburg, D-14558, Germany

Location

Related Publications (2)

  • 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.

  • Keyhani-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.

MeSH Terms

Interventions

SugarsSucroseGlucoseisomaltuloseGalactoseSweetening AgentsSaccharinsinigrinintybinoxytocin, 1-alpha-mercaptoacetic acid-iso-Asn(5)-GastroscopySodium-Glucose Transporter 1

Intervention Hierarchy (Ancestors)

CarbohydratesDisaccharidesOligosaccharidesPolysaccharidesHexosesMonosaccharidesFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesThiazolesSulfur CompoundsOrganic ChemicalsBenzothiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresSodium-Glucose Transport ProteinsSymportersIon PumpsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMonosaccharide Transport ProteinsSolute Carrier ProteinsMembrane Proteins

Study Officials

  • Andreas FH Peiffer, Prof

    German Institute of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 18, 2014

Study Start

December 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations