- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01931930
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
Status
Completed
Conditions
Intervention / Treatment
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
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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.
|
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTS656/12
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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