Quantitative Investigation of bioappearance and metabolism of trigonelline and its bioactive roasting products in coffee brew

Organizational Data

DRKS-ID:
DRKS00004524
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2013-03-12
Last update in DRKS:
2022-03-24
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

In a human intervention study, roast coffee brew is administered to the participating healthy volunteers. The study aims at quantitative analysis of coffee derived compounds and selected metabolic parameters in the plasma, which are discussed to be involved in diabetes type 2 prevention, inflammation and activation of phase I/II enzyme systems. The control group consists of a similar healthy group of volunteers without intervention.

Brief summary in scientific language

Beside caffeine, the betaine trigonelline is the second most abundant alkaloid in raw coffee. This thermolabile compound is largely degraded during coffee roasting giving rise to a variety of pyridine-derivatives.1 One of these pyrolysis products is niacin, also known as vitamin B3. Since roast coffee contains a fairly high amount of niacin, consumption of the brew supplies a significant portion of the daily demand (~17 mg/d).2,3 A further quantitatively important roast product of trigonelline is the recently discovered N-methylpyridinium (NMP), which can reach concentrations of 20-40 mg/L and beyond in the roast coffee brew.4-6 In murine animal models, administration of NMP induced the activity of Phase I/II detoxification enzymes. NMP was subsequently suggested to excert “chemoprotective” properties in living systems.7 Recent research substantiated this hypothesis, as NMP was found to activate antioxidant-reponse-element (ARE-) dependent gene expression of several detoxification enzymes in human colon carcinoma cell line HT29.8 Trigonelline, the progenitor of NMP, is still highly abundant in roast coffee brew despite the heavy losses suffered during roasting. Based on its anti-diabetic properties in animal studies, trigonelline is discussed in the context of diabetes treatment in man.9-11 1 Viani, R.; Horman, I. (1974) Thermal Behaviour of Trigonelline J. Food Sci. 39, 1216-1217 2 Taguchi, H.; Sakaguchi, M.; Shimabayashi, Y. (1985) Trigonelline Content in Coffee Beans and the Thermal Conversion of Trigonelline into Nicotinic Acid during the Roasting of Coffee Beans. Agric. Biol. Chem. 49, 3467-3471 3 Experts Group on Vitamins and Minerals, Review of Niacin. London Food Standard Agency 2002; http://www.food.gov.uk/multimedia/pdfs/evm-01-11r.pdf 4 Stadler, R.H.; Varga, N.; Hau, J.; Vera, F.A.; Welti, D. (2002) Alkylpyridiniums. 1. Formation in model systems via thermal degradation of trigonelline. J. Agric. Food Chem. 50, 1192-1199 5 Stadler, R.H.; Varga, N.; Milo, C.; Schilter, B.; Vera, F.A.; Welti, D. (2002) Alkylpyridiniums. 2. Isolation and quantification in roasted and ground coffees. J. Agric. Food Chem. 50, 1200-1206; 6 Weiss, C.; Rubach, M.; Lang, R.; Seebach, E.; Blumberg, S.; Frank, O.; Hofmann, T.; Somoza, V. (2010) Measurement of the intracellular pH in human stomach cells: a novel approach to evaluate the gastric acid secretory potential of coffee beverages. J. Agric. Food Chem. 58, 1976-1985. 7 Somoza et al., 2003, J. Agric. Food Chem, 51, 6861-6869 8 Boettler, U.; Sommerfeld, K.; Volz, N.; Pahlke, G.; Teller, N.; Somoza, V.; Lang, R.; Hofmann, T.; Marko, D. (2011) Coffee constituents as modulators of Nrf2 nuclear translocation and ARE (EpRE)-dependent gene expression. J. Nutr. Biochem., 22, 426-440. 9 Yoshinari, O.; Sato, H.; Igarashi, K. (2009) Anti-diabetic effects of pumpkin and its compounds, trigonelline and nicotinic acid, on Goto-Kakizaki rats. Biosci. Biotechnol. Biochem. 73, 1033-1041. 10 Mishinksy, J.; Joseph, B.; Sulman, F.G. (1967) Hypoglycaemic effect of trigonelline. Lancet, 1311-1312. 11 Lang, R.; Yagar, E.F.; Eggers, R.; Hofmann, T. (2008) Quantitative Investigation of Trigonelline, Nicotinic Acid, and Nicotinamide in Foods, Urine, and Plasma by Means of LC-MS/MS and Stable Isotope Dilution Analysis. J. Agric. Food Chem. 56, 11114-11121

Health condition or problem studied

Free text:
healthy volunteers
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
coffee-group ( once only 350ml coffee)
Arm 2:
control-group (once only 350ml water)

Endpoints

Primary outcome:
One of the aims is to collect quantitative plasma data on coffee constituents (in particular trigonelline and N-methylpyridinium) and metabolites of niacin by means of HPLC-MS/MS methods (stable isotope dilution assays), and analyse pharmacokinetic properties of the compounds. Measuring points are before and 15, 30, 45, 60, 120, 240, 360 und 480 min after coffee ingestion. First morning urine and urine is collected in a 2h time interval all day long.
Secondary outcome:
Further, quantitation of carnitine, saturated acylcarnitine (C12 up to C18), and unsaturated acylcarnitine (C18:1, C18:2, C18:3) (Measuring points are before and 15, 30, 45, 60, 120, 240, 360 und 480 min after ingestion of coffee or water) shall give a hint as to whether coffee ingestion affects lipid metabolism.

Study Design

Purpose:
Basic research/physiological study
Allocation:
Non-randomized controlled study
Control:
  • Other
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Freising

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2009-09-15
Planned study completion date:
No Entry
Actual Study Completion Date:
2012-12-14
Target Sample Size:
28
Final Sample Size:
27

Inclusion Criteria

Sex:
All
Minimum Age:
20 Years
Maximum Age:
40 Years
Additional Inclusion Criteria:
metabolically healthy volunteers

Exclusion Criteria

no consuming diseases

Addresses

Primary Sponsor

Address:
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrstuhl für Ernährungsmedizin
Prof. Dr. med. Hans Hauner
Gregor-Mendel-Str. 2
85350 Freising-Weihenstephan
Germany
Telephone:
08161-712000
Fax:
08161-712097
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Lehrstuhl für Lebensmittelchemie und Molekulare Sensorik
Dr.rer.nat. Roman Lang
Lise-Meitner-Straße 34
85354 Freising-Weihenstephan
Germany
Telephone:
08161-712903
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Address:
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München
Dipl oec troph Yu-Mi Lee
Gregor-Mendel-Straße 2
85350 Freising-Weihenstephan
Germany
Telephone:
08161-712007
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Principal Investigator

Address:
Lehrstuhl für Lebensmittelchemie und Molekulare Sensorik
Dr.rer.nat. Roman Lang
Lise-Meitner-Straße 34
85354 Freising-Weihenstephan
Germany
Telephone:
08161-712903
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Address:
Lehrstuhl für Lebensmittelchemie und molekulare Sensorik TU München
Lise-Meitner-Straße 34
85354 Freising-Weihenstephan
Germany
Telephone:
08161-712901
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

Address:
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrstuhl für Ernährungsmedizin
Gregor-Mendel-Str. 2
85350 Freising-Weihenstephan
Germany
Telephone:
08161-712000
Fax:
08161-712097
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Address:
Ethikkommission der Fakultät für Medizin der Technischen Universität München
Ismaninger Str. 22
81675 München
Germany
Telephone:
+49-89-41404371
Fax:
+49-89-41404199
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2009-07-10
Ethics committee number:
2496/09
Vote of the Ethics Committee:
Approved
Date of the vote:
2009-07-29

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry