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

NCT ID: NCT05603416

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-09
• Study Completion Date: 2023-04-30

Brief Summary

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Benegut

Dietary Supplement: Perilla frutescens extract

Group Type: ACTIVE_COMPARATOR

Perilla frutescens extract

Intervention Type: DIETARY_SUPPLEMENT

oral dissolvable powder - dosage 300mg

Placebo

Dietary Supplement: Placebo, no active ingredient

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

oral dissolvable powder - dosage 300mg no active ingredient

Interventions

Perilla frutescens extract

oral dissolvable powder - dosage 300mg

Intervention Type: DIETARY_SUPPLEMENT

Placebo

oral dissolvable powder - dosage 300mg no active ingredient

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vital Solutions GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biotesys GmbH

Esslingen am Neckar, , Germany

Countries

Germany

Other Identifiers

BTS1308/19

Identifier Type: -

Identifier Source: org_study_id