- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03140930
The Effect of Duodenal, Ileal or Combined Infusion of Tastants on Food Intake
Rationale: The appearance of tastants in the small intestine can result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. The effects of intraduodenal and/or intraileal infusion of a combination of tastants (sweet (rebaudioside A), bitter (quinine) en umami (monosodium glutamate(MSG))) and placebo on ad libitum food intake, satiation and gastrointestinal symptoms will be investigated.
Objective: To investigate the effect of intraduodenal, intraileal and combined infusion of a combination of tastants versus infusion of placebo on food intake.
Secondary objectives:
- To compare the effect of intraduodenal versus intraileal versus combined intraduodenal and intraileal delivery of a combination of tastants on satiation.
- To assess the effect of intraduodenal and/or intraileal delivery of a combination of tastants on gastrointestinal symptoms/complaints.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Limburg
-
Maastricht, Limburg, Nederländerna, 6229HX
- Maastricht University Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
- BMI between 18 and 25 kg/m2)
- Weight stable over at least the last 6 months
Exclusion Criteria:
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- Dieting (medically prescribed, vegetarian, diabetic, microbiological, biological dynamic)
- Pregnancy, lactation
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
- Smoking
- Weight <60kg
- Non-tasters of sweet, bitter or umami
- Evidence of MSG-hypersensitivity or Chinese restaurant syndrome
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Duodenal tastants, ileal placebo
Duodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of placebo (tap water)
|
Duodenal infusion of combination of tastants (sweet, bitter and umami)
Ileal infusion of placebo (tap water)
|
|
Experimentell: Duodenal placebo, ileal tastants
Duodenal infusion of placebo (tap water), ileal infusion of combination of tastants (sweet, bitter and umami)
|
Ileal infusion of combination of tastants (sweet, bitter and umami)
Duodenal infusion of placebo (tap water)
|
|
Experimentell: Duodenal tastants, ileal tastants
Duodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of combination of tastants (sweet, bitter and umami)
|
Duodenal infusion of combination of tastants (sweet, bitter and umami)
Ileal infusion of combination of tastants (sweet, bitter and umami)
|
|
Placebo-jämförare: Duodenal placebo, ileal placebo
Duodenal infusion of placebo (tap water), ileal infusion of placebo (tap water)
|
Ileal infusion of placebo (tap water)
Duodenal infusion of placebo (tap water)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ad libitum meal intake
Tidsram: 5 weeks
|
Difference in ad libitum meal intake (as measured during ad libitum pasta meal) at end of the test day.
|
5 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Satiation
Tidsram: 5 weeks
|
Difference in satiation (as measured by VAS) per time point.
|
5 weeks
|
|
GI-symptoms
Tidsram: 5 weeks
|
Difference in gastro-intestinal symptoms (as measured by VAS) per time point.
|
5 weeks
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Ad AM Masclee, Prof., Maastricht University Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- NL59530.068.16
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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