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

Healthy Clinical Trial

Official title:

The Role of Bitter Taste Receptors Expressed in the Gastrointestinal Tract in Altering Food Intake and Gastrointestinal Motility

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02759926
• Other study ID #: BitterMotilityHungerFoodIntake
• Status: Active, not recruiting
• Phase: N/A
• First received: April 25, 2016
• Last updated: April 29, 2016
• Start date: August 2011

Study information

• Verified date: April 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Obesity

Intervention

Drug:
• Denatonium benzoate

• Quinine hydrochloride

• Tap water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gastrointestinal motility measured by antroduodenal high-resolution manometry		2 hours after administration, continuous measurement with high resolution manometry	No
Secondary	Change in gut hormone release measured by specific radioactive immunoassays		2 hours after administration, blood sample every 10 min	No
Secondary	Change in food intake measured by the caloric content of the meal		ad libitum food intake for 1 hour, 40 min after administration	No
Secondary	Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm		2 hours after administration, assessment every 5 min	No