Healthy VolunteersNCT05603416
Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects
A study testing Perilla frutescens extract in people with Healthy Volunteers, run by Vital Solutions GmbH at 1 site in Germany.
Trial summary
To determine the relief of GI discomfort after overfeeding with a high caloric meal. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Perilla frutescens extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 9 Nov 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects- a Randomized, Placebo-controlled Cross-over Study
To determine the relief of GI discomfort after overfeeding with a high caloric meal.
- Conditions
- Healthy Volunteers
- Being tested
- Perilla frutescens extract, Placebo
- Keywords
- Digestive health, Perilla frutescens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perilla frutescens extractDietary supplement
oral dissolvable powder - dosage 300mg
PlaceboDietary supplement
oral dissolvable powder - dosage 300mg no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Benegut | Active comparator | Dietary Supplement: Perilla frutescens extract Receives: Dietary Supplement: Perilla frutescens extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, no active ingredient Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)
Secondary outcomes (3)
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
Measured: Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)
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.
Measured: Day 1 immediately prior going to bed, day 2 immediately after wake up
Monitoring of related adverse events
Reporting of adverse effects to evaluate tolerability
Measured: up to 14 hours after intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start9 Nov 2022
- Primary completion2 Mar 2023
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vital Solutions GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603416
- Sponsor's protocol ID
- BTS1308/19
- Status last verified
- Nov 2022
- First submitted
- 21 Oct 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects- a Randomized, Placebo-controlled Cross-over Study
- ClinicalTrials.gov ID
- NCT05603416
- Acronym / sponsor ID
- BTS1308/19
- Conditions
- Healthy Volunteers
- Keywords
- Digestive health, Perilla frutescens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vital Solutions GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the relief of GI discomfort after overfeeding with a high caloric meal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benegut | Active comparator | Dietary Supplement: Perilla frutescens extractDietary Supplement: Perilla frutescens extract |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary Supplement: Placebo, no active ingredient |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perilla frutescens extractoral dissolvable powder - dosage 300mg | Dietary supplement | Benegut |
| Placebooral dissolvable powder - dosage 300mg no active ingredient | Dietary supplement | Placebo |
Primary outcome
Overall gastrointestinal discomfort assessed with a visual analogue scale (VAS)
Time frame: 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.
3 secondary outcomes
Assessment of gastrointestinal symptoms on a 6-point Likert scale
Time frame: Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)
Follow up assessment of gastrointestinal symptoms on a 6-point Likert scale
Time frame: Day 1 immediately prior going to bed, day 2 immediately after wake up
Monitoring of related adverse events
Time frame: up to 14 hours after intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perilla frutescens extract in people with Healthy Volunteers, run by Vital Solutions GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall gastrointestinal discomfort assessed with a visual analogue scale (VAS) (time frame: Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.