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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05603416
• Other study ID #: BTS1308/19
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2022
• Source: Vital Solutions GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 30, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Perilla frutescens extract
oral dissolvable powder - dosage 300mg
• Placebo
oral dissolvable powder - dosage 300mg no active ingredient

Locations

Country	Name	City	State
Germany	Biotesys GmbH	Esslingen

Sponsors (1)

Lead Sponsor	Collaborator
Vital Solutions GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	Monitoring of related adverse events	Reporting of adverse effects to evaluate tolerability	up to 14 hours after intake