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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02219295
Other study ID # BMBF 11005D
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2011
Est. completion date September 2014

Study information

Verified date June 2020
Source German Institute of Human Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Healthy persons

Exclusion Criteria:

- Tumor in history

- Pregnancy

- Severe illness in history

- Bodymass index below 18

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Department of Clinical Nutrition Bergholz-Rehbrücke Brandenburg

Sponsors (2)

Lead Sponsor Collaborator
German Institute of Human Nutrition Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in the Area under the Curve (AUC) for PYY in different bitter tasting substances oral application of sinigrin, lactucopicrin and other extracts of vegetables and umami, getting insight into the different bitter receptors 3 years
Primary 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 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 3 years
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