Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort

Recruitment & Eligibility

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 & Design

Arm && Interventions

Group	Intervention	Description
Perilla extract	Perilla extract	Experimental arm: Perilla extract
Maltodextrin	Maltodextrin	Placebo arm: Maltodextrin

Primary Outcome Measures

Name	Time	Method
daily gastrointestinal symptoms	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

Name	Time	Method
validated questionnaires	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)
stool consistency	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.
Adverse events	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.
Stool frequency	reported at days with stool during 4 week intervention	The stool frequency was reported on each day with bowel movement.

Recruitment & Eligibility