Bitter Tastants and Reflux

NCT ID: NCT03777787

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2019-05-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Bitter

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

Group Type: EXPERIMENTAL

Denatonium Benzoate

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

A single intragastric administration of placebo (water)

Group Type: PLACEBO_COMPARATOR

Water

Intervention Type: DIETARY_SUPPLEMENT

A single intragastric administration of water

Interventions

Denatonium Benzoate

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

Intervention Type: DIETARY_SUPPLEMENT

Water

A single intragastric administration of water

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S61251

Identifier Type: -

Identifier Source: org_study_id