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Table 1 In- and exclusion criteria for the participation at the study

From: Perilla Extract improves gastrointestinal discomfort in a randomized placebo controlled double blind human pilot study

Inclusion criteria

Exclusion criteria

Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility

Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries

Reduced bowel movements defined as an average of >1 and ≤ 3.5 stools per week for at least the previous 6 months

Relevant history, presence of any medical disorder or intake of medication/dietary supplements, potentially interfering with this trial at screening

BMI: 19-30 kg/m2

Subjects with stool frequency of ≤ 1 stool every 7 days or > 3.5 stools per week

Gastrointestinal symptoms of at least 5 points

Subjects not willing to avoid pre- and probiotics for the duration of the study

Male or female

Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks

Age ≥ 30 and ≤ 70 years

Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)

Nonsmoker

Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject

Written consent to participate in the study

Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study

Able and willing to follow the study protocol procedures

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