Clinical trial NCT05603416: Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects
Official title: Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects- a Randomized, Placebo-controlled Cross-over Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Keywords: Digestive health
Perilla frutescens
Lead sponsor: Vital Solutions GmbH
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To determine the relief of GI discomfort after overfeeding with a high caloric meal.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
* Age ≥ 25 and ≤ 70 years
* BMI: 19-30 kg/m2
* Overall GI discomfort after high caloric meal of at least 5 on the VAS scale
* Male or female
* Written consent to participate in the study
* Subject is able and willing to follow the study protocol procedures
* If applicable, stable intake of chronic medication of at least 3 months

Exclusion Criteria:

Criteria for inclusion:

* Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
* Age ≥ 25 and ≤ 70 years
* BMI: 19-30 kg/m2
* Overall GI discomfort after high caloric meal of at least 5 on the VAS scale
* Male or female
* Written consent to participate in the study
* Subject is able and willing to follow the study protocol procedures
* If applicable, stable intake of chronic medication of at least 3 months

Criteria for exclusion:

* Relevant history, presence of any medical disorder (e.g. cancer, severe liver disease, severe renal disease, severe cardiovascular disease)
* Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or use of PPI (proton pump inhibitors) or other digestive auxiliaries potentially interfering with this study at screening
* Intake of antibiotics in the last 4 weeks
* Women suffering from distinct PMS symptoms
* Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
* Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)
* Vegetarian or vegan nutrition style
* Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
* Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study
* Subject who according to the study staff's opinion is not suitable for participation in the study

Primary outcomes:
measure: Overall gastrointestinal discomfort assessed with a visual analogue scale (VAS)
timeFrame: Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)
Secondary outcomes:
measure: Assessment of gastrointestinal symptoms on a 6-point Likert scale
timeFrame: Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)
measure: Follow up assessment of gastrointestinal symptoms on a 6-point Likert scale
timeFrame: Day 1 immediately prior going to bed, day 2 immediately after wake up
measure: Monitoring of related adverse events
timeFrame: up to 14 hours after intake
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Biotesys GmbH
Study officials:
References: