Clinical trial NCT01931930: Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort
Official title: Effect of Perilla Extract on Improvement of Intestinal Discomfort and Bowel Function in Healthy Volunteers With Gastrointestinal Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain/ Discomfort
Slightly Constipation
Keywords: Gastrointestinal discomfort
Perilla frutescens
bloating
abdominal discomfort
human study
healthy subjects
Lead sponsor: Amino Up Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-30
Enrollment: 47
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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

Primary outcomes:
measure: daily gastrointestinal symptoms
timeFrame: was assessed daily during 4 week intervention
Secondary outcomes:
measure: validated questionnaires
timeFrame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
measure: stool consistency
timeFrame: reported at days with stool during 4 week intervention
measure: Adverse events
timeFrame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
measure: Stool frequency
timeFrame: reported at days with stool during 4 week intervention
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
affiliation: BioTeSys GmbH
name: Daniel Menzel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.