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OpenTrials
Completed

NCT Number: NCT03777787

Bitter Tastants and Reflux

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Denatonium Benzoate

Dietary Supplement

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

Water

Dietary Supplement

A single intragastric administration of water

Primary outcomes

  1. Change in number of TLESRs

    Time frame: 1 week

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

Secondary outcomes

  1. Change in reflux

    Time frame: 1 week

    The change in the number of reflux events between placebo and bitter condition.

  2. Change in motility pattern

    Time frame: 1 week

    The change in the intragastric pressure between placebo and bitter condition.

  3. Change in motilin concentration

    Time frame: 1 week

    The change in motilin concentration between placebo and bitter condition.

  4. Change in symptoms

    Time frame: 1 week

    Change in the number of volunteers reporting gastrointestinal symptoms between placebo and bitter condition

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

The Relationship Between Acute Administration of a Bitter Compound and Transient Lower Esophageal Sphincter Relaxations and Reflux Events in Healthy Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2018
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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