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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140930
• Other study ID #: NL59530.068.16
• Status: Completed
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: November 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Tastants duodenal
Duodenal infusion of combination of tastants (sweet, bitter and umami)
• Tastants ileal
Ileal infusion of combination of tastants (sweet, bitter and umami)
• Placebo duodenal
Duodenal infusion of placebo (tap water)
• Placebo ileal
Ileal infusion of placebo (tap water)

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ad libitum meal intake	Difference in ad libitum meal intake (as measured during ad libitum pasta meal) at end of the test day.	5 weeks
Secondary	Satiation	Difference in satiation (as measured by VAS) per time point.	5 weeks
Secondary	GI-symptoms	Difference in gastro-intestinal symptoms (as measured by VAS) per time point.	5 weeks