Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To determine the relief of GI discomfort after overfeeding with a high caloric meal.

Official Title
-----------------
Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects- a Randomized, Placebo-controlled Cross-over Study

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Dietary Supplement: Perilla frutescens extract
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Benegut<br>Dietary Supplement: Perilla frutescens extract | Dietary Supplement: Perilla frutescens extract<br>* oral dissolvable powder - dosage 300mg<br>|
| Placebo Comparator: Placebo<br>Dietary Supplement: Placebo, no active ingredient | Dietary Supplement: Placebo<br>* oral dissolvable powder - dosage 300mg no active ingredient<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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) | 
| Follow up 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, as well as overall gastrointestinal discomfort. | Day 1 immediately prior going to bed, day 2 immediately after wake up | 
| Monitoring of related adverse events | Reporting of adverse effects to evaluate tolerability | up to 14 hours after intake | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digestive health, Perilla frutescens