Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort

Amino Up Chemicals

Status

Completed

Conditions

Slightly Constipation

Abdominal Pain/ Discomfort

Treatments

Dietary Supplement: Perilla extract

Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01931930

BTS656/12

Details and patient eligibility

About

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).

Enrollment

47 patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts Healthy Volunteers

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