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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
47
BioTeSys GmbH
Esslingen am Neckar, Germany
daily gastrointestinal symptoms
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: was assessed daily during 4 week intervention
validated questionnaires
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)
Time frame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
stool consistency
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: reported at days with stool during 4 week intervention
Adverse events
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: assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
Stool frequency
The stool frequency was reported on each day with bowel movement.
Time frame: reported at days with stool during 4 week intervention
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