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Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01931930
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : August 30, 2013
Information provided by (Responsible Party):
Amino Up Chemicals Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Abdominal Pain/ Discomfort Slightly Constipation Dietary Supplement: Perilla extract Dietary Supplement: Maltodextrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Perilla Extract on Improvement of Intestinal Discomfort and Bowel Function in Healthy Volunteers With Gastrointestinal Discomfort
Study Start Date : July 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: Perilla extract
Experimental arm: Perilla extract
Dietary Supplement: Perilla extract
Placebo Comparator: Maltodextrin
Placebo arm: Maltodextrin
Dietary Supplement: Maltodextrin

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. Stool frequency [ Time Frame: reported at days with stool during 4 week intervention ]
    The stool frequency was reported on each day with bowel movement.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01931930

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BioTeSys GmbH
Esslingen, Germany, 73728
Sponsors and Collaborators
Amino Up Chemicals Co., Ltd.
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Principal Investigator: Daniel Menzel, PhD BioTeSys GmbH

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Amino Up Chemicals Co., Ltd. Identifier: NCT01931930     History of Changes
Other Study ID Numbers: BTS656/12
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013
Keywords provided by Amino Up Chemicals Co., Ltd.:
Gastrointestinal discomfort
Perilla frutescens
abdominal discomfort
human study
healthy subjects
Additional relevant MeSH terms:
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Abdominal Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Neurologic Manifestations