Effect of POCO on Gastric Function in HV

NCT03682835 | Completed

• 1 other identifier: POCO-study
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

gastric motility; gastric emptying; nutrient volume tolerance; peppermint oil; caraway oil

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Gastric emptying

  Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid

• Gastrointestinal symptoms

  assessment by questionnaire (100 mm Visual Analogue Scale) every 15 minutes, until the end of the intragastric pressure measurement

• Gastrointestinal peptide hormone levels

  Hormone levels were assessed before and every 15 minutes after intake of POCO/placebo until the end of the intragastric pressure measurement

Study Arms (2)

Placebo treatment arm

PLACEBO COMPARATOR

Placebo: 2 capsules per dose, 2 doses per study day.

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.

Dietary Supplement: FDGard

Interventions

FDGard DIETARY_SUPPLEMENT

capsule containing peppermint oil and caraway oil

POCO treatment arm

Placebo OTHER

Placebo capsule containing cellulose

Placebo treatment arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

TARGID

Leuven, 3000, Belgium

Location

Study Officials

• Jan Tack, MD

  UZ Leuven / KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, parallel, single-blind, placebo-controlled

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 25, 2018
• Study Start: October 13, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)