Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort

NCT ID: NCT01931930

Last Updated: 2013-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-11-30

Brief Summary

In the current study the effects of proprietary Perilla frutescens leaf extract in comparison to Maltodextrin, a fully digestible carbohydrate (placebo control), on gastrointestinal discomfort and bowel function were investigated. The study was performed double-blind and placebo-controlled with a 4 week intervention period. Study products were taken two times daily (each one capsule before breakfast and dinner).

Conditions

Abdominal Pain/ Discomfort; Slightly Constipation

Keywords

Gastrointestinal discomfort; Perilla frutescens; bloating; abdominal discomfort; human study; healthy subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Perilla extract

Experimental arm: Perilla extract

Group Type: EXPERIMENTAL

Perilla extract

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Placebo arm: Maltodextrin

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Perilla extract

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

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.
• BMI: 19-30 kg/m2
• Reduced bowel movements defined as an average of >1 and ≤ 3.5 stools per week for at least the previous 6 months
• Gastrointestinal symptoms of at least 5 points
• Male or female
• Age ≥ 30 and ≤ 70 years
• Nonsmoker
• Written consent to participate in the study
• Able and willing to follow the study protocol procedures

Exclusion Criteria

• Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
• Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening
• Subjects with stool frequency of ≤ 1 stool every 7 days or > 3,5 stools per week
• Subjects not willing to avoid pre- and probiotics for the duration of the study
• Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
• Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)
• 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.
• Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results.
• Known food intolerance or allergy.
• Subject involved in any clinical or food study within the preceding month

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amino Up Chemicals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Menzel, PhD

Role: PRINCIPAL_INVESTIGATOR

BioTeSys GmbH

Locations

BioTeSys GmbH

Esslingen am Neckar, , Germany

Countries

Germany

References

Buchwald-Werner S, Fujii H, Reule C, Schoen C. Perilla extract improves gastrointestinal discomfort in a randomized placebo controlled double blind human pilot study. BMC Complement Altern Med. 2014 May 27;14:173. doi: 10.1186/1472-6882-14-173.

Reference Type: DERIVED

PMID: 24885816 (View on PubMed)

Other Identifiers

BTS656/12

Identifier Type: -

Identifier Source: org_study_id