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Clinical Trials/NCT03140930
NCT03140930
Completed
Not Applicable

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

Maastricht University Medical Center1 site in 1 country19 target enrollmentMay 12, 2017
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Maastricht University Medical Center
Enrollment
19
Locations
1
Primary Endpoint
Ad libitum meal intake
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
May 12, 2017
End Date
May 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tim Klaassen

MD

Maastricht University Medical Center

Eligibility Criteria

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)
  • Weight \<60kg
  • Non-tasters of sweet, bitter or umami
  • Evidence of MSG-hypersensitivity or Chinese restaurant syndrome

Outcomes

Primary Outcomes

Ad libitum meal intake

Time Frame: 5 weeks

Difference in ad libitum meal intake (as measured during ad libitum pasta meal) at end of the test day.

Secondary Outcomes

  • Satiation(5 weeks)
  • GI-symptoms(5 weeks)

Study Sites (1)

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