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Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort

Primary Purpose

Abdominal Pain/ Discomfort, Slightly Constipation

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Perilla extract

Maltodextrin

About this trial

This is an interventional supportive care trial for Abdominal Pain/ Discomfort focused on measuring Gastrointestinal discomfort, Perilla frutescens, bloating, abdominal discomfort, human study, healthy subjects

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

BioTeSys GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Perilla extract

Maltodextrin

Arm Description

Experimental arm: Perilla extract

Placebo arm: Maltodextrin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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.

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.

Stool frequency

The stool frequency was reported on each day with bowel movement.

Full Information

NCT ID

NCT01931930

First Posted

August 23, 2013

Last Updated

August 29, 2013

Sponsor

Amino Up Chemicals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01931930

Brief Title

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

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amino Up Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Pain/ Discomfort, Slightly Constipation

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Perilla extract

Arm Type

Experimental

Arm Description

Experimental arm: Perilla extract

Arm Title

Maltodextrin

Arm Type

Placebo Comparator

Arm Description

Placebo arm: Maltodextrin

Intervention Type

Dietary Supplement

Intervention Name(s)

Perilla extract

Intervention Type

Dietary Supplement

Intervention Name(s)

Maltodextrin

Primary Outcome Measure Information:

Title

daily gastrointestinal symptoms

Description

Time Frame

was assessed daily during 4 week intervention

Secondary Outcome Measure Information:

Title

validated questionnaires

Description

Time Frame

assessed at visit 1 (before) and at visit 2 (after 4 week intervention)

Title

stool consistency

Description

The stool consistency was rated referring to the Bristol stool scale. A scale indicated with pictures how the stool consistency can be rated.

Time Frame

reported at days with stool during 4 week intervention

Title

Adverse events

Description

Time Frame

assessed at visit 1 (before) and at visit 2 (after 4 week intervention)

Title

Stool frequency

Description

The stool frequency was reported on each day with bowel movement.

Time Frame

reported at days with stool during 4 week intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Menzel, PhD

Organizational Affiliation

BioTeSys GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

BioTeSys GmbH

City

Esslingen

ZIP/Postal Code

73728

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24885816

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.

Results Reference

derived

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Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort

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