NCT01956838

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. We will investigate the effects of intraduodenal infusion of quinine 75mg (bitter), rebaudioside A 540mg (sweet), monosodium glutamate 2g (umami), a combination of these tastants (quinine, rebaudioside A, monosodium glutamate) and placebo (5 test days in total) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides CCK and GLP-1. Study design: To assess the effect of intraduodenal infusion of single ingredients and a combination of tastants (bitter, umami and sweet) on ad libitum food intake. Secondary Objective(s):

  1. 1.To investigate the effect of intraduodenal delivery of a combination of tastants on satiation.
  2. 2.To assess the effect of intraduodenal delivery of a combination of tastants on gastrointestinal hormone release.
  3. 3.To assess the effects of the tastants quinine, rebaudioside A and monosodium glutamate on the parameters as mentioned under the primary objective, and under secondary objectives 1 and 2.
  4. 4.To compare the effects, as mentioned under the primary objective, and under secondary objectives 1 and 2, of the combination of tastants to those of the three single tastants quinine, rebaudioside A and monosodium glutamate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable obesity

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

Study Start

First participant enrolled

September 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

11 months

First QC Date

September 17, 2013

Last Update Submit

October 13, 2014

Conditions

Keywords

food intaketastantsobesity

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 testday

    5 weeks

Secondary Outcomes (2)

  • Satiation

    5 weeks

  • Gut hormones

    5 weeks

Study Arms (5)

Umami

EXPERIMENTAL

intraduodenal infusion of umami

Dietary Supplement: umami

sweet

EXPERIMENTAL

intraduodenal infusion of sweet tastant

Dietary Supplement: sweet

bitter

EXPERIMENTAL

intraduodenal infusion of bitter tastant

Dietary Supplement: bitter

combination

EXPERIMENTAL

intraduodenal infusion of a combination of tastants (umami, bitter and sweet)

Dietary Supplement: umamiDietary Supplement: bitterDietary Supplement: sweet

placebo

PLACEBO COMPARATOR

intraduodenal infusion of placebo (tap water)

Interventions

umamiDIETARY_SUPPLEMENT

intraduodenal infusion of umami tastant

Umamicombination
bitterDIETARY_SUPPLEMENT

intraduodenal infusion of bitter tastant

bittercombination
sweetDIETARY_SUPPLEMENT

intraduodenal infusion of sweet tastant

combinationsweet

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, macrobiological, biological dynamic)
  • Pregnancy, lactation
  • Excessive alcohol consumption (\>20 alcoholic consumptions per week)
  • Smoking
  • Blood donation within 3 months before the study period
  • Self-admitted HIV-positive state
  • 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, Maastricht, Netherlands

Location

Related Publications (1)

  • van Avesaat M, Troost FJ, Ripken D, Peters J, Hendriks HF, Masclee AA. Intraduodenal infusion of a combination of tastants decreases food intake in humans. Am J Clin Nutr. 2015 Oct;102(4):729-35. doi: 10.3945/ajcn.115.113266. Epub 2015 Aug 19.

MeSH Terms

Conditions

Obesity

Interventions

Candy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Prof Masclee, MD,PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2013

First Posted

October 8, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations