Investigation of Benegut® on Immediate GI Discomfort Reli... | NCT05603416

NCT05603416

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Benegut	Active Comparator	Dietary Supplement: Perilla frutescens extract	Dietary Supplement: Perilla frutescens extract
Placebo	Placebo Comparator	Dietary Supplement: Placebo, no active ingredient	Dietary Supplement: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Perilla frutescens extract	Dietary Supplement	oral dissolvable powder - dosage 300mg	Benegut

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall gastrointestinal discomfort assessed with a visual analogue scale (VAS)	In the current study, GI discomfort, following a high caloric meal, will be assessed with a visual analogue scale (VAS) before and after meal at defined timepoints.	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	Description	Time Frame
Assessment of gastrointestinal symptoms on a 6-point Likert scale	In the current study, the following GI symptoms will be assessed: Feeling of fullness / tension, Passage of gas/ Flatulence, Bloating, GI discomfort, cramps, pain, Rumbling, Burping, Heartburn symptom, Nausea, Urge of defecate	Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)

Eligibility Module

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