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

Vital Solutions Swiss

Status

Active, not recruiting

Conditions

Healthy Volunteers

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Perilla frutescens extract

Study type

Interventional

Funder types

Industry

Identifiers

BTS1308/19

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

All

Ages

25 to 70 years old

Volunteers

Accepts Healthy Volunteers

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