BioTeSys GmbH
Esslingen am Neckar, 73728, Germany
NCT Number: NCT01931930
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).
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Notify Me30 year–70 year
All sexes
Interventional
Not applicable
Esslingen am Neckar, 73728, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: reported at days with stool during 4 week intervention
The stool frequency was reported on each day with bowel movement.
Amino Up Chemicals Co., Ltd.
Industry
Effect of Perilla Extract on Improvement of Intestinal Discomfort and Bowel Function in Healthy Volunteers With Gastrointestinal Discomfort
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