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Completed

NCT Number: 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:

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tastants duodenal

Dietary Supplement

Duodenal infusion of combination of tastants (sweet, bitter and umami)

Tastants ileal

Dietary Supplement

Ileal infusion of combination of tastants (sweet, bitter and umami)

Placebo duodenal

Dietary Supplement

Duodenal infusion of placebo (tap water)

Placebo ileal

Dietary Supplement

Ileal infusion of placebo (tap water)

Primary outcomes

  1. 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

  1. Satiation

    Time frame: 5 weeks

    Difference in satiation (as measured by VAS) per time point.

  2. GI-symptoms

    Time frame: 5 weeks

    Difference in gastro-intestinal symptoms (as measured by VAS) per time point.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 4, 2017
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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