NCT05603416

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 9, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

March 17, 2023

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

October 21, 2022

Last Update Submit

March 16, 2023

Conditions

Healthy Volunteers

Keywords

Digestive healthPerilla frutescens

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

  • 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

  • Monitoring of related adverse events

    up to 14 hours after intake

Study Arms (2)

Benegut

ACTIVE COMPARATOR

Dietary Supplement: Perilla frutescens extract

Dietary Supplement: Perilla frutescens extract

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo, no active ingredient

Dietary Supplement: Placebo

Interventions

Perilla frutescens extractDIETARY_SUPPLEMENT

oral dissolvable powder - dosage 300mg

Benegut
PlaceboDIETARY_SUPPLEMENT

oral dissolvable powder - dosage 300mg no active ingredient

Placebo

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biotesys GmbH

Esslingen am Neckar, 73728, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2022

First Posted

November 2, 2022

Study Start

November 9, 2022

Primary Completion

March 2, 2023

Study Completion

April 30, 2023

Last Updated

March 17, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)