Healthy Volunteers
Conditions
Keywords
Digestive health, Perilla frutescens
Brief summary
To determine the relief of GI discomfort after overfeeding with a high caloric meal.
Interventions
DIETARY_SUPPLEMENTPerilla frutescens extract
oral dissolvable powder - dosage 300mg
DIETARY_SUPPLEMENTPlacebo
oral dissolvable powder - dosage 300mg no active ingredient
Sponsors
Vital Solutions GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed