Trial document




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  DRKS00020498

Trial Description

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Title

Plasma kinetic of the concentration of D9- and D3-choline and their metabolites in the plasma of male adults after administration of four D9-marked choline supplements

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Trial Acronym

CHOLINORAL IIb

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URL of the Trial

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Brief Summary in Lay Language

Comparison of the plasma kinetics of different D9-labeled choline components in tracer dosage in male adults

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Brief Summary in Scientific Language

To date clinical pilot studies on choline supplementation using choline chloride were performed in preterm infants and Cystic Fibrosis (CF) patients. In both patient groups this resulted in (1.) a normalization of plasma choline concentrations, and in CF patients lung function was improved and increased liver fat reduced. (3) In both groups, single labeling with D9-choline chloride resulted in a better understanding of choline and phospholipid metabolism. In this study different candidates of optimized choline supplementation will be given to healthy adult males, in form of a single oral tracer dosage of the D9-labeled analogues of organic esters (D9-alpha-glycerophosphorylcholine [D9-alpha-GPC], D9-phosphorylcholine and D9-phosphatidylcholine [D9-PC]), compared to the free D9-choline salt (D9-choline chloride). In plasma and erythrocyte membranes, D9-enrichment of choline and its deuterated metabolites will be determined over time, to assess differences in the intermediary metabolism of the individual components.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00020498
  •   2020/01/22
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  •   yes
  •   Approved
  •   322/2019B01, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   E63.8 -  Other specified nutritional deficiencies
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Interventions/Observational Groups

  •   [D9-Methyl]-Choline chloride 3.6 mg/kg, blood samples 5 min before and 0,5h, 1h, 1,5h, 2h, 2,5h, 3h, 4h, 5h, 6h, 9h, 24h, 33h, 48h, 3d, 4d und 7d after intake, wash-out phase of 6 weeks.
  •   [D9-Methyl]-Phosphorylcholine chloride-Ca-Salz 6.4 mg/kg, blood samples 5 min before and 0,5h, 1h, 1,5h, 2h, 2,5h, 3h, 4h, 5h, 6h, 9h, 24h, 33h, 48h, 3d, 4d und 7d after intake, wash-out phase of 6 weeks.
  •   [D9-methyl]-alpha-GPC 6.4 mg/kg, blood samples 5 min before and 0,5h, 1h, 1,5h, 2h, 2,5h, 3h, 4h, 5h, 6h, 9h, 24h, 33h, 48h, 3d, 4d und 7d after intake, wash-out phase of 6 weeks.
  •   [D9-Methyl]-POPC 18.6 mg/kg, blood samples 5 min before and 0,5h, 1h, 1,5h, 2h, 2,5h, 3h, 4h, 5h, 6h, 9h, 24h, 33h, 48h, 3d, 4d und 7d after intake, wash-out phase of 6 weeks.
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

AUC of the D9-choline plasma concentration

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Secondary Outcome

1. AUC of D9-Batain
2. AUC of D9-PC
3. Time until the maximum plasma concentration of D9-choline is reached
4. Time until the maximum plasma concentration of D9-choline derivates is reached
5. Velocity of increase and decrease of plasma concentrations during 7 days
6. Distribution of the labeling to the different D9-choline labeled metabolites

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/03/01
  •   6
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. >= 18 years
2. male

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Exclusion Criteria

1. chronic alcohol abuse
2. acute diseases
3. chronic diseases that change the lipid and cholin metabolism (i.e. untreated Hypothyreosis, Hyperthyreosis, diseases of the lipid metabolism, diseases of the digestive tract and his glands, diabetes, pancreatitis, chronic kidney diseases, ventricular funcitonal limitations that influence the liver function)
4. vegan diet
5. nutritional supplements containing choline

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Addresses

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    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Kinder- und Jugendheilkunde
    • Mr.  Prof.  Wolfgang  Bernhard 
    • Calwerstraße 7
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Kinder- und Jugendheilkunde
    • Mr.  Prof.  Wolfgang  Bernhard 
    • Calwerstraße 7
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Hipp-Werk Georg Hipp
    • Georg-Hipp-straße 7
    • 85276  Pfaffenhofen
    • Germany
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    •   +49(0)8441-757-129
    •   +49(0)8441-757-777-129
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    •   http://www.hipp.de
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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