NCT03682835

Effect of POCO on Gastric Function in HV

The Effect of a Combination of Peppermint Oil and Caraway Oil on Gastric Motility, Nutrient Volume Tolerance, Gastric Emptying and Gastrointestinal Hormones in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate changes in gastric motility (including gastric accommodation), nutrient volume tolerance, gastric emptying and gastrointestinal hormones in healthy volunteers after an acute intake of a combination of peppermint oil and caraway oil, compared to placebo. In addition, the effect of a combination of peppermint oil and caraway oil on appetite-related sensations and upper gastrointestinal symptoms will be assessed. Gastric emptying rate will be assessed using a 13C breath test. Intragastric pressure (IGP) will be measured using high-resolution manometry in fasted state and during intragastric infusion of a nutrient drink (350 mL or until full satiation). Appetite-related sensations and gastrointestinal symptoms were rated during IGP measurements. Blood samples were collected to assess peptide hormone levels.

Detailed description

This study aims to investigate changes in gastric motility (including gastric accommodation), nutrient volume tolerance, gastric emptying and gastrointestinal hormones in healthy volunteers after an acute intake of a combination of peppermint oil and caraway oil, compared to placebo. In addition, the effect of a combination of peppermint oil and caraway oil on appetite-related sensations and upper gastrointestinal symptoms will be assessed. These outcomes will be studied on 2 study days. On study day 1, gastric emptying rate will be assessed using a 13C breath test 30 minutes after intake of study medication. This test is followed by an intragastric pressure (IGP) measurement during which 350 mL of a nutrient drink will be intragastrically infused 30 minutes after intake of study medication. On the second study day, IGP will be measured in fasted state for 4 hours after intake of study medication. Hereafter, a second dose of study medication will be administered. Thirty minutes later, a nutrient drink will be infused until the participant is fully satiated. Appetite-related sensations and gastrointestinal symptoms will be rated during IGP measurements on a 100mm VAS. Blood samples will be collected to assess peptide hormone levels.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	FDGard	capsule containing peppermint oil and caraway oil
OTHER	Placebo	Placebo capsule containing cellulose

Timeline

• Start date: 2017-10-13
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2018-09-25
• Last updated: 2018-09-25

Locations

1 site across 1 country: Belgium