Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2017-10-13
2018-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Placebo treatment arm
Placebo: 2 capsules per dose, 2 doses per study day.
Placebo
Placebo capsule containing cellulose
POCO treatment arm
FDGard Capsule containing a combination of peppermint oil (41,5mg) and caraway oil (50mg); 2 capsules per dose, 2 doses per study day.
FDGard
capsule containing peppermint oil and caraway oil
Interventions
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FDGard
capsule containing peppermint oil and caraway oil
Placebo
Placebo capsule containing cellulose
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
* Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
Exclusion Criteria
* Subject with a BMI ≤ 20 or BMI ≥ 25.
* Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
* Subject has a significant heart, lung, liver or kidney disease.
* Subject has any history of a neurological disorder.
* Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.
* History or current use of drugs that can affect gastrointestinal function, motility or sensitivity or gastric acidity.
* History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).
* Subject consumes excessive amounts of alcohol, defined as \>14 units per week for women and \>21 units per week for men.
* 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.
* High caffeine intake (\> 500 ml coffee daily or equivalent).
* Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
* Recent participation (\<30 days) or simultaneous participation in another clinical study.
* Radiation exposure exceeding 1mSv during the last year (from other studies or medical procedures).
* Subject has had a PET-scan or CT-scan in the last year.
18 Years
50 Years
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Jan Tack, MD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven / KU Leuven
Locations
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TARGID
Leuven, , Belgium
Countries
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Other Identifiers
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POCO-study
Identifier Type: -
Identifier Source: org_study_id
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