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The Effect of Duodenal, Ileal or Combined Infusion of Tastants on Food Intake

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Obesity

Treatments

Dietary Supplement: Placebo duodenal
Dietary Supplement: Tastants ileal
Dietary Supplement: Placebo ileal
Dietary Supplement: Tastants duodenal

Study type

Interventional

Funder types

Other

Identifiers

NCT03140930
NL59530.068.16

Details and patient eligibility

About

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:

  1. To compare the effect of intraduodenal versus intraileal versus combined intraduodenal and intraileal delivery of a combination of tastants on satiation.
  2. To assess the effect of intraduodenal and/or intraileal delivery of a combination of tastants on gastrointestinal symptoms/complaints.

Enrollment

19 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

19 participants in 4 patient groups, including a placebo group

Duodenal tastants, ileal placebo
Experimental group
Description:
Duodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of placebo (tap water)
Treatment:
Dietary Supplement: Placebo ileal
Dietary Supplement: Tastants duodenal
Duodenal placebo, ileal tastants
Experimental group
Description:
Duodenal infusion of placebo (tap water), ileal infusion of combination of tastants (sweet, bitter and umami)
Treatment:
Dietary Supplement: Placebo duodenal
Dietary Supplement: Tastants ileal
Duodenal tastants, ileal tastants
Experimental group
Description:
Duodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of combination of tastants (sweet, bitter and umami)
Treatment:
Dietary Supplement: Tastants duodenal
Dietary Supplement: Tastants ileal
Duodenal placebo, ileal placebo
Placebo Comparator group
Description:
Duodenal infusion of placebo (tap water), ileal infusion of placebo (tap water)
Treatment:
Dietary Supplement: Placebo duodenal
Dietary Supplement: Placebo ileal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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