The Effect of Bitter, Umami and Sweet Tastants on Food Intake

• ClinicalTrials.gov Identifier: NCT01956838
• Recruitment Status: Completed
• First Posted: October 8, 2013
• Last Update Posted: October 15, 2014
• Sponsor: Maastricht University Medical Center
• Information provided by (Responsible Party): Maastricht University Medical Center

Tracking Information

• First Submitted Date: September 17, 2013
• First Posted Date: October 8, 2013
• Last Update Posted Date: October 15, 2014
• Study Start Date: September 2013
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 30, 2013)

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 testday

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 30, 2013)

• Satiation [ Time Frame: 5 weeks ]
  Difference in satiation (as measured by VAS) per time point
• Gut hormones [ Time Frame: 5 weeks ]
  Measurements in plasma levels of the gut hormones CCK, GLP-1, insulin and glucose

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Bitter, Umami and Sweet Tastants on Food Intake
• Official Title: The Effect of Bitter, Umami and Sweet Tastants on Food Intake

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. To investigate the effect of intraduodenal delivery of a combination of tastants on satiation.
2. To assess the effect of intraduodenal delivery of a combination of tastants on gastrointestinal hormone release.
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. 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Basic Science
• Condition: Obesity

Intervention

• Dietary Supplement: umami
  intraduodenal infusion of umami tastant
• Dietary Supplement: bitter
  intraduodenal infusion of bitter tastant
• Dietary Supplement: sweet
  intraduodenal infusion of sweet tastant

Study Arms

• Experimental: Umami
  intraduodenal infusion of umami
  Intervention: Dietary Supplement: umami
• Experimental: sweet
  intraduodenal infusion of sweet tastant
  Intervention: Dietary Supplement: sweet
• Experimental: bitter
  intraduodenal infusion of bitter tastant
  Intervention: Dietary Supplement: bitter
• Experimental: combination
  intraduodenal infusion of a combination of tastants (umami, bitter and sweet)
  Interventions:

  • Dietary Supplement: umami
  • Dietary Supplement: bitter
  • Dietary Supplement: sweet
• Placebo Comparator: placebo
  intraduodenal infusion of placebo (tap water)

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 30, 2013): 15
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

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, 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT01956838
• Other Study ID Numbers: NL44428.068.13/METC 13-2-025
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Maastricht University Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Maastricht University Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Prof Masclee, MD,PhD; Maastricht University Medical Center

• PRS Account: Maastricht University Medical Center
• Verification Date: October 2014