Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects
Study Details
Study Description
Brief Summary
To determine the relief of GI discomfort after overfeeding with a high caloric meal.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Benegut Dietary Supplement: Perilla frutescens extract |
Dietary Supplement: Perilla frutescens extract
oral dissolvable powder - dosage 300mg
|
| Placebo Comparator: Placebo Dietary Supplement: Placebo, no active ingredient |
Dietary Supplement: Placebo
oral dissolvable powder - dosage 300mg no active ingredient
|
Outcome Measures
Primary Outcome Measures
- Overall gastrointestinal discomfort assessed with a visual analogue scale (VAS) [Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)]
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.
Secondary Outcome Measures
- Assessment of gastrointestinal symptoms on a 6-point Likert scale [Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)]
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
- Follow up assessment of gastrointestinal symptoms on a 6-point Likert scale [Day 1 immediately prior going to bed, day 2 immediately after wake up]
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.
- Monitoring of related adverse events [up to 14 hours after intake]
Reporting of adverse effects to evaluate tolerability
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
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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
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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)
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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
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Intake of antibiotics in the last 4 weeks
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Women suffering from distinct PMS symptoms
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Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
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Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)
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Vegetarian or vegan nutrition style
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Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
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Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Biotesys GmbH | Esslingen | Germany | 73728 |
Sponsors and Collaborators
- Vital Solutions GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BTS1308/19