Trial document





This trial has been registered retrospectively.
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  DRKS00004524

Trial Description

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Title

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

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Trial Acronym

[---]*

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URL of the Trial

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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.

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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

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Organizational Data

  •   DRKS00004524
  •   2013/03/12
  •   [---]*
  •   yes
  •   Approved
  •   2496/09, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   healthy volunteers
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Interventions/Observational Groups

  •   coffee-group ( once only 350ml coffee)
  •   control-group (once only 350ml water)
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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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.

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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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2009/09/15
  •   28
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   40   Years
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Additional Inclusion Criteria

metabolically healthy volunteers

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Exclusion Criteria

no consuming diseases

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Addresses

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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrstuhl für Ernährungsmedizin
    • Mr.  Prof. Dr. med.  Hans  Hauner 
    • Gregor-Mendel-Str. 2
    • 85350  Freising-Weihenstephan
    • Germany
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    • Lehrstuhl für Lebensmittelchemie und molekulare Sensorik TU München
    • Mr.  Prof.Dr.  Thomas  Hofmann 
    • Lise-Meitner-Straße 34
    • 85354  Freising-Weihenstephan
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Lehrstuhl für Lebensmittelchemie und Molekulare Sensorik
    • Mr.  Dr.rer.nat.  Roman  Lang 
    • Lise-Meitner-Straße 34
    • 85354  Freising-Weihenstephan
    • Germany
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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München
    • Ms.  Dipl oec troph  Yu-Mi  Lee 
    • Gregor-Mendel-Straße 2
    • 85350  Freising-Weihenstephan
    • Germany
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrstuhl für Ernährungsmedizin
    • Mr.  Prof. Dr. med.  Hans  Hauner 
    • Gregor-Mendel-Str. 2
    • 85350  Freising-Weihenstephan
    • Germany
    end of 1:1-Block address materialSupport
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    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Lehrstuhl für Lebensmittelchemie und molekulare Sensorik TU München
    • Mr.  Prof.Dr.  Thomas  Hofmann 
    • Lise-Meitner-Straße 34
    • 85354  Freising-Weihenstephan
    • Germany
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    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/14
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* This entry means the parameter is not applicable or has not been set.