Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort

August 29, 2013 updated by: Amino Up Chemicals Co., Ltd.

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

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Esslingen, Germany, 73728
        • BioTeSys GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
daily gastrointestinal symptoms
Time Frame: was assessed daily during 4 week intervention
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
Time Frame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention)

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.

  1. Patient assessment of constipation symptoms (PAC SYM)
  2. Patents assessment of constipation quality of life (PAC QOL)
  3. Perceived stress questionnaire (PSQ20)
assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
stool consistency
Time Frame: reported at days with stool during 4 week intervention
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
Time Frame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
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
Time Frame: reported at days with stool during 4 week intervention
The stool frequency was reported on each day with bowel movement.
reported at days with stool during 4 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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