Bitter Tastants and Reflux

NCT03777787 | Completed

• 1 other identifier: S61251
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Recently the relationship between intragastric pressure (IGP) and reflux events after a meal was investigated, both in gastro-esophageal reflux disease (GERD) patients and in healthy volunteers. Ingestion of a meal was accompanied by a drop in IGP. However, the magnitude of this drop varied and was inversely correlated with the number of transient lower esophageal sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in healthy volunteers: a smaller meal-induced drop in IGP was associated with a higher rate of reflux events and vice versa. This finding suggests that a smaller meal-induced drop may act as a trigger for reflux. It has been demonstrated that bitter administration leads to a smaller meal-induced drop. Therefore, bitter can be a dietary trigger for TLESRs facilitating the occurrence of symptoms of GERD. To evaluate this hypothesis, the researchers will study the relationship between bitter and the occurrence of TLESRs and reflux events in healthy volunteers. Additionally, it has been demonstrated that administering bitter also influences the concentration of motilin. Therefore, the research team will also measure the concentration of motilin to investigate whether changes in motilin concentrations can influence the number of TLESRs, via a change in gastric tone.

Conditions

Gastro Esophageal Reflux

Keywords

Bitter; TLESRs; Gastric tone

Outcome Measures

Primary Outcomes (1)

• Change in number of TLESRs

  Changes in the number of transient lower esophageal sphincter relaxations (TLESRs) between the placebo and bitter condition.

  1 week

Secondary Outcomes (4)

• Change in reflux

  1 week

• Change in motility pattern

  1 week

• Change in motilin concentration

  1 week

• Change in symptoms

  1 week

Study Arms (2)

Bitter

EXPERIMENTAL

A single intragastric administration of denatonium benzoate (1 µmol/kg)

Dietary Supplement: Denatonium Benzoate

Placebo

PLACEBO COMPARATOR

A single intragastric administration of placebo (water)

Dietary Supplement: Water

Interventions

Denatonium Benzoate DIETARY_SUPPLEMENT

A single intragastric administration of denatonium benzoate (1 µmol/kg)

Bitter

Water DIETARY_SUPPLEMENT

A single intragastric administration of water

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female volunteers
• Age between 18 and 65
• Written informed consent

You may not qualify if:

• A history of any upper GI symptoms or GI surgery;
• Psychological disorders;
• Concomitant use of other medication or treatments except for oral contraceptives;
• Use of medication altering esophageal or GI motility;
• Pregnant or nursing women.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

denatonium; Water

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 17, 2018
• Study Start: January 14, 2019
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

BE (1)