Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-25 @ 8:53 AM
Study NCT ID:
NCT03682835
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2018-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of POCO on Gastric Function in HV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, parallel, single-blind, placebo-controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2018-09-21', 'studyFirstSubmitQcDate': '2018-09-21', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric motility', 'timeFrame': '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.', 'description': 'motility of the stomach, including gastric accommodation'}], 'secondaryOutcomes': [{'measure': 'Gastric emptying', 'timeFrame': 'Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid', 'description': 'Gastric emptying was assess by a 13C-octanoid acid breath test'}, {'measure': 'Gastrointestinal symptoms', 'timeFrame': 'assessment by questionnaire (100 mm Visual Analogue Scale) every 15 minutes, until the end of the intragastric pressure measurement', 'description': 'Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm'}, {'measure': 'Gastrointestinal peptide hormone levels', 'timeFrame': 'Hormone levels were assessed before and every 15 minutes after intake of POCO/placebo until the end of the intragastric pressure measurement', 'description': 'change in gastrointestinale hormone levels induced by POCO intake'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric motility', 'gastric emptying', 'nutrient volume tolerance', 'peppermint oil', 'caraway oil'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.\n\nGastric 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is male or female between 18 and 50 of age.\n* Subject has a BMI between 20 and 25 and has a stable body weight for at least 3 consecutive months at start of study and no history of behavioral, therapeutic or surgical treatment aiming at or leading to weight loss/gain.\n* Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.\n* Subject understands the study procedures and agrees to participate in the study by giving written informed consent.\n\nExclusion Criteria:\n\n* Subject is under age of legal consent, pregnant or breastfeeding.\n* Subject with a BMI ≤ 20 or BMI ≥ 25.\n* Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.\n* Subject has a significant heart, lung, liver or kidney disease.\n* Subject has any history of a neurological disorder.\n* Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.\n* History or current use of drugs that can affect gastrointestinal function, motility or sensitivity or gastric acidity.\n* History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).\n* Subject consumes excessive amounts of alcohol, defined as \\>14 units per week for women and \\>21 units per week for men.\n* Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including "recreational use") of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study.\n* High caffeine intake (\\> 500 ml coffee daily or equivalent).\n* Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.\n* Recent participation (\\<30 days) or simultaneous participation in another clinical study.\n* Radiation exposure exceeding 1mSv during the last year (from other studies or medical procedures).\n* Subject has had a PET-scan or CT-scan in the last year.'}, 'identificationModule': {'nctId': 'NCT03682835', 'acronym': 'POCO', 'briefTitle': 'Effect of POCO on Gastric Function in HV', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'POCO-study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo treatment arm', 'description': 'Placebo: 2 capsules per dose, 2 doses per study day.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'POCO treatment arm', 'description': 'FDGard Capsule containing a combination of peppermint oil (41,5mg) and caraway oil (50mg); 2 capsules per dose, 2 doses per study day.', 'interventionNames': ['Dietary Supplement: FDGard']}], 'interventions': [{'name': 'FDGard', 'type': 'DIETARY_SUPPLEMENT', 'description': 'capsule containing peppermint oil and caraway oil', 'armGroupLabels': ['POCO treatment arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo capsule containing cellulose', 'armGroupLabels': ['Placebo treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'TARGID', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Jan Tack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven / KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}