NCT03140930

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

May 12, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

May 2, 2017

Last Update Submit

November 14, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Satiation

    5 weeks

  • GI-symptoms

    5 weeks

Study Arms (4)

Duodenal tastants, ileal placebo

EXPERIMENTAL

Duodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of placebo (tap water)

Dietary Supplement: Tastants duodenalDietary Supplement: Placebo ileal

Duodenal placebo, ileal tastants

EXPERIMENTAL

Duodenal infusion of placebo (tap water), ileal infusion of combination of tastants (sweet, bitter and umami)

Dietary Supplement: Tastants ilealDietary Supplement: Placebo duodenal

Duodenal tastants, ileal tastants

EXPERIMENTAL

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

Dietary Supplement: Tastants duodenalDietary Supplement: Tastants ileal

Duodenal placebo, ileal placebo

PLACEBO COMPARATOR

Duodenal infusion of placebo (tap water), ileal infusion of placebo (tap water)

Dietary Supplement: Placebo duodenalDietary Supplement: Placebo ileal

Interventions

Tastants duodenalDIETARY_SUPPLEMENT

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

Duodenal tastants, ileal placeboDuodenal tastants, ileal tastants
Tastants ilealDIETARY_SUPPLEMENT

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

Duodenal placebo, ileal tastantsDuodenal tastants, ileal tastants
Placebo duodenalDIETARY_SUPPLEMENT

Duodenal infusion of placebo (tap water)

Duodenal placebo, ileal placeboDuodenal placebo, ileal tastants
Placebo ilealDIETARY_SUPPLEMENT

Ileal infusion of placebo (tap water)

Duodenal placebo, ileal placeboDuodenal tastants, ileal placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ad AM Masclee, Prof.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

May 12, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

November 15, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)