Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort

Effect of Perilla Extract on Improvement of Intestinal Discomfort and Bowel Function in Healthy Volunteers With Gastrointestinal Discomfort

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).

Study Overview

• Status: Completed
• Conditions: Abdominal Pain/ Discomfort; Slightly Constipation
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: Perilla extract

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Perilla extract; Experimental arm: Perilla extract	Dietary supplement: Perilla extract
PLACEBO_COMPARATOR: Maltodextrin; Placebo arm: Maltodextrin	Dietary supplement: Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
daily gastrointestinal symptoms	The following gastrointestinal were rated and reported by the study participants on a daily based. Bloating, rumbling, feeling of fullness, passage of gas, abdominal discomfort (pain and cramps). The rating was done based on a number scale. 0 not at all and 4 extremely.	was assessed daily during 4 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
validated questionnaires	Three validated questionnaires were used. Two of them were specially designed to evaluate gastrointestinal symptoms and quality of life of people with constipation. The third questionnaire was a validated questionnaire to report stress levels and related changes of stress levels.; Patient assessment of constipation symptoms (PAC SYM); Patents assessment of constipation quality of life (PAC QOL); Perceived stress questionnaire (PSQ20)	assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
stool consistency	The stool consistency was rated referring to the Bristol stool scale. A scale indicated with pictures how the stool consistency can be rated.	reported at days with stool during 4 week intervention
Adverse events	All adverse events which might be linked to the study product were reported. As the tested study product is a food product being safe for consumption as food no specific parameter to define safety were defined.	assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
Stool frequency	The stool frequency was reported on each day with bowel movement.	reported at days with stool during 4 week intervention

Collaborators and Investigators

• Sponsor: Amino Up Chemicals Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: August 23, 2013
• First Submitted That Met QC Criteria: August 29, 2013
• First Posted (ESTIMATE): August 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: healthy subjects; bloating; abdominal discomfort; Perilla frutescens; human study; Gastrointestinal discomfort
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Constipation
• Other Study ID Numbers: BTS656/12