The Effect of Bitter Taste Receptor Agonists on The Gastrointestinal Tract, Hunger and Food Intake

NCT02759926 | Unknown

• 1 other identifier: BitterMotilityHungerFoodIntake
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigators aimed at evaluating the role of bitter taste receptors in the gastrointestinal tract (GIT). Intragastric or intraduodenal administration of denatonium benzoate (DB) or quinine hydrochloride were compared with placebo administration for their effects on lingual sensitivity, gastrointestinal motility (both in the fasted and fed state), gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and cholecystokinin (CCK)) and food intake. Differences between lean and obese subjects will be evaluated.

Conditions

Healthy; Obesity

Keywords

Healthy volunteers; Obesity; Bitter

Outcome Measures

Primary Outcomes (1)

• Change in gastrointestinal motility measured by antroduodenal high-resolution manometry

  2 hours after administration, continuous measurement with high resolution manometry

Secondary Outcomes (3)

• Change in gut hormone release measured by specific radioactive immunoassays

  2 hours after administration, blood sample every 10 min

• Change in food intake measured by the caloric content of the meal

  ad libitum food intake for 1 hour, 40 min after administration

• Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm

  2 hours after administration, assessment every 5 min

Study Arms (6)

Denatonium benzoate intragastric

ACTIVE COMPARATOR

1 µmol/kg bodyweight (10mM) was administered as a bolus into the stomach through a nasogastric feeding tube.

Drug: Denatonium benzoate

Quinine hydrochloride intragastric

ACTIVE COMPARATOR

10 µmol/kg bodyweight (100mM) was administered as a bolus into the stomach through a nasogastric feeding tube.

Drug: Quinine hydrochloride

Tap water intragastric

PLACEBO COMPARATOR

An equal amount of tap water was administered as a bolus into the stomach through a nasogastric feeding tube.

Drug: Tap water

Denatonium benzoate intraduodenal

ACTIVE COMPARATOR

1 µmol/kg bodyweight (10mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.

Drug: Denatonium benzoate

Quinine hydrochloride intraduodenal

ACTIVE COMPARATOR

10 µmol/kg bodyweight (100mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.

Drug: Quinine hydrochloride

Tap water intraduodenal

PLACEBO COMPARATOR

An equal amount of tap water was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.

Drug: Tap water

Interventions

Denatonium benzoate DRUG

Denatonium benzoate intraduodenal; Denatonium benzoate intragastric

Quinine hydrochloride DRUG

Quinine hydrochloride intraduodenal; Quinine hydrochloride intragastric

Tap water DRUG

Tap water intraduodenal; Tap water intragastric

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI\>30 kg/m² for the obese volunteers
• BMI\<30 kg/m² for the lean volunteers
• Subject is capable and willing to give informed consent
• Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception

You may not qualify if:

• Female volunteer is pregnant or breastfeeding
• Gastrointestinal diseases, major abdominal surgery
• Major psychiatric illnesses
• Volunteers that use drugs affecting the GIT or the central nervous system (CNS)
• Volunteers that suffer from diabetes mellitus
• Volunteers suffering from an endocrine disease such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor…
• Volunteers that have undergone surgical procedure for weight loss

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (1)

• Deloose E, Janssen P, Corsetti M, Biesiekierski J, Masuy I, Rotondo A, Van Oudenhove L, Depoortere I, Tack J. Intragastric infusion of denatonium benzoate attenuates interdigestive gastric motility and hunger scores in healthy female volunteers. Am J Clin Nutr. 2017 Mar;105(3):580-588. doi: 10.3945/ajcn.116.138297. Epub 2017 Feb 1.

  PMID: 28148502 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

denatonium; Quinine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jan Tack, Prof

  Universitaire Ziekenhuizen KU Leuven

  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: April 25, 2016
• First Posted: May 3, 2016
• Study Start: August 1, 2011
• Primary Completion: November 1, 2015
• Last Updated: May 3, 2016

Record last verified: 2016-04