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The Role of the Endocannabinoid System in Sweet Taste Intensity and Liking (Sweed)

22. maj 2017 opdateret af: Wageningen University
The endocannabinoid (eCB) system, a neurochemical signalling system consisting of CB-receptors and their endogenous ligands, has been found to be involved in food intake of sweet and palatable foods. Activation of the eCB system increases food intake and vice versa. The mechanism behind this effect is still unknown and the current study aims at clarifying why sweet food intake increases. It is hypothesized that sweet taste intensity increases and that sweet taste is experienced as more pleasant.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
    • Gelderland
      • Wageningen, Gelderland, Holland, 6703 HD
        • Wageningen University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 35 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • BMI: 18.5 - 25 kg/m2
  • Incidental cannabis use for at least one year, at least four times per year, but less than once a week.
  • Dutch-speaking
  • Willing to comply with the study procedures
  • Having given written informed consent

Exclusion Criteria:

  • Not meeting the inclusion criteria
  • Restraint eating (men: score > 2.90)
  • Lack of appetite
  • Having difficulties with swallowing/eating
  • Usage of an energy restricted diet during the last two months
  • Weight loss or weight gain of 5kg or more during the last two months
  • Stomach or bowel disease
  • Diabetes, thyroid disease, other endocrine disorders
  • Use of daily medication except paracetamol
  • Having taste or smell disorders (self-report)
  • Being allergic/intolerant for products under study
  • Previously experienced an adverse reaction to cannabinoids (e.g. anxiety, paranoia, nausea)
  • Having (had) a schizophrenia or other psychotic illness
  • Having a family history of schizophrenia or other psychotic illness
  • Working at the Division of Human Nutrition (WUR)
  • Current participation in other research from the Division of Human Nutrition (WUR)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: T-C-P
Order of administrations: tetrahydrocannabinol - cannabidiol - placebo
Medicin: Placebo
Medicin: tetrahydrocannabinol
Andre navne:
  • THC
  • delta-9-tetrahydrocannabinol
Medicin: cannabidiol
Andre navne:
  • CBD
Eksperimentel: T-P-C
Order of administrations: tetrahydrocannabinol - placebo - cannabidiol
Medicin: Placebo
Medicin: tetrahydrocannabinol
Andre navne:
  • THC
  • delta-9-tetrahydrocannabinol
Medicin: cannabidiol
Andre navne:
  • CBD
Eksperimentel: C - T - P
Order of administrations: cannabidiol - tetrahydrocannabinol - placebo
Medicin: Placebo
Medicin: tetrahydrocannabinol
Andre navne:
  • THC
  • delta-9-tetrahydrocannabinol
Medicin: cannabidiol
Andre navne:
  • CBD
Eksperimentel: C - P - T
Order of administrations: cannabidiol - placebo - tetrahydrocannabinol
Medicin: Placebo
Medicin: tetrahydrocannabinol
Andre navne:
  • THC
  • delta-9-tetrahydrocannabinol
Medicin: cannabidiol
Andre navne:
  • CBD
Eksperimentel: P - T - C
Order of administrations: placebo - tetrahydrocannabinol - cannabidiol
Medicin: Placebo
Medicin: tetrahydrocannabinol
Andre navne:
  • THC
  • delta-9-tetrahydrocannabinol
Medicin: cannabidiol
Andre navne:
  • CBD
Eksperimentel: P - C - T
Order of administrations: placebo - cannabidiol - tetrahydrocannabinol
Medicin: Placebo
Medicin: tetrahydrocannabinol
Andre navne:
  • THC
  • delta-9-tetrahydrocannabinol
Medicin: cannabidiol
Andre navne:
  • CBD

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relation between sweet taste intensity and liking
Tidsramme: 15 minutes after intervention
The main study parameter is the relation between sucrose intensity scaling (psychophysics) and liking (psychohedonics) of drinks with the different sucrose concentrations. These scores will be assessed after six participants and at end of the study.
15 minutes after intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ranking order of pleasantness of different drinks with different levels of sucrose.
Tidsramme: 25 minutes after intervention
Ranking order will be assessed after 6 participants and at end of the study
25 minutes after intervention
Preferences for different kinds of foods
Tidsramme: 45 minutes after intervention (15 minutes after top-up dose)
Preference for foods high in one of three macronutrients (carbohydrate, protein, fat) or low in energy
45 minutes after intervention (15 minutes after top-up dose)
Ad libitum intake
Tidsramme: 35 minutes after intervention (5 minutes after top-up dose)
Ad libitum intake of a chocolate-based drink
35 minutes after intervention (5 minutes after top-up dose)
Change of plasma levels of (endo-)cannabinoids and satiety hormones
Tidsramme: One hour after intervention
One hour after intervention
Polymorphisms
Tidsramme: At test session, i.e., 2 weeks before first intervention
The genetic determination of the enzymes responsible for the metabolism of THC and CBD.
At test session, i.e., 2 weeks before first intervention

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Descriptives
Tidsramme: At inclusion of participants
General subject characteristics, e.g age, restrained eating score and other lifestyle and medical parameters
At inclusion of participants
Appetite ratings
Tidsramme: During each test session
During each test session, appetite ratings will be assessed at several time points
During each test session
Subjective feelings
Tidsramme: During each test session
During each test sessions, participants will rate the effects of the intervention.
During each test session
Perception
Tidsramme: 20 minutes after intervention
Participants will rate the intensity of different shades of grey.
20 minutes after intervention
Sweet taste intensity
Tidsramme: 15 minutes after intervention
Sucrose intensity of drinks (psychophysics) of drinks with different sucrose concentrations. This will be assessed after six participants and at end of the study.
15 minutes after intervention
Liking of sweet taste
Tidsramme: 15 minutes after intervention
Liking (psychohedonics) of drinks with the different sucrose concentrations. This will be assessed after six participants and at end of the study.
15 minutes after intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wageningen University

Efterforskere

  • Ledende efterforsker: Suzanne EM de Bruijn, MSc, Wageningen University
  • Studiestol: Gerry Jager, Dr., Wageningen University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2014

Primær færdiggørelse (Faktiske)

16. april 2015

Studieafslutning (Faktiske)

16. april 2015

Datoer for studieregistrering

Først indsendt

25. marts 2014

Først indsendt, der opfyldte QC-kriterier

9. april 2014

Først opslået (Skøn)

11. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NL44758.081.13
  • 2013-002555-14 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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