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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo treatment arm | Placebo Comparator | Placebo: 2 capsules per dose, 2 doses per study day. |
|
| POCO treatment arm | Experimental | FDGard Capsule containing a combination of peppermint oil (41,5mg) and caraway oil (50mg); 2 capsules per dose, 2 doses per study day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDGard | Dietary Supplement | capsule containing peppermint oil and caraway oil |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric motility | motility of the stomach, including gastric accommodation | Fed state: until 2 hours after the start of the liquid meal. Liquid meal started 30 minutes after POCO/placebo intake. Fasted state: until 4h after intake of POCO/placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying | Gastric emptying was assess by a 13C-octanoid acid breath test | Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid |
| Gastrointestinal symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Tack, MD | UZ Leuven / KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TARGID | Leuven | 3000 | Belgium |
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randomized, parallel, single-blind, placebo-controlled
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| Placebo |
| Other |
Placebo capsule containing cellulose |
|
Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm
| assessment by questionnaire (100 mm Visual Analogue Scale) every 15 minutes, until the end of the intragastric pressure measurement |
| Gastrointestinal peptide hormone levels | change in gastrointestinale hormone levels induced by POCO intake | Hormone levels were assessed before and every 15 minutes after intake of POCO/placebo until the end of the intragastric pressure measurement |