HealthyPOCONCT03682835
Effect of POCO on Gastric Function in HV
A study testing FDGard in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FDGard
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Oct 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female between 18 and 50 of age.
- 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.
Who cannot join
- Subject is under age of legal consent, pregnant or breastfeeding.
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- FDGard, Placebo
- Keywords
- gastric motility, gastric emptying, nutrient volume tolerance, peppermint oil, caraway oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDGardDietary supplement
capsule containing peppermint oil and caraway oil
PlaceboOther
Placebo capsule containing cellulose
| Study group | Role | What they receive |
|---|---|---|
| Placebo treatment arm | Placebo comparator | Placebo: 2 capsules per dose, 2 doses per study day. Receives: Other: Placebo |
| 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. Receives: Dietary Supplement: FDGard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric motility
motility of the stomach, including gastric accommodation
Measured: 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.
Secondary outcomes (3)
Gastric emptying
Gastric emptying was assess by a 13C-octanoid acid breath test
Measured: Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid
Gastrointestinal symptoms
Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm
Measured: 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
Measured: Hormone levels were assessed before and every 15 minutes after intake of POCO/placebo until the end of the intragastric pressure measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start13 Oct 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, parallel, single-blind, placebo-controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD, Principal investigator, UZ Leuven / KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682835
- Sponsor's protocol ID
- POCO-study
- Acronym
- POCO
- Status last verified
- Sep 2018
- First submitted
- 21 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03682835
- Acronym / sponsor ID
- POCO / POCO-study
- Conditions
- Healthy
- Keywords
- gastric motility, gastric emptying, nutrient volume tolerance, peppermint oil, caraway oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized, parallel, single-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo treatment arm | Placebo comparator | Other: PlaceboPlacebo: 2 capsules per dose, 2 doses per study day. |
| POCO treatment arm | Experimental | Dietary Supplement: FDGardFDGard Capsule containing a combination of peppermint oil (41,5mg) and caraway oil (50mg); 2 capsules per dose, 2 doses per study day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is male or female between 18 and 50 of age.
- 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.
Key exclusion criteria (15 listed)
- Subject is under age of legal consent, pregnant or breastfeeding.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDGardcapsule containing peppermint oil and caraway oil | Dietary supplement | POCO treatment arm |
| PlaceboPlacebo capsule containing cellulose | Other | Placebo treatment arm |
Primary outcome
Gastric motility
Time frame: 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.
motility of the stomach, including gastric accommodation
3 secondary outcomes
Gastric emptying
Time frame: Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid
Gastrointestinal symptoms
Time frame: assessment by questionnaire (100 mm Visual Analogue Scale) every 15 minutes, until the end of the intragastric pressure measurement
Gastrointestinal peptide hormone levels
Time frame: Hormone levels were assessed before and every 15 minutes after intake of POCO/placebo until the end of the intragastric pressure measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, MD principal investigator
UZ Leuven / KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDGard in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric motility (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.