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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perilla extract | Experimental | Experimental arm: Perilla extract |
|
| Maltodextrin | Placebo Comparator | Placebo arm: Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perilla extract | Dietary Supplement |
| ||
| Maltodextrin |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | was assessed daily during 4 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Menzel, PhD | BioTeSys GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | 73728 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24885816 | Derived | Buchwald-Werner S, Fujii H, Reule C, Schoen C. Perilla extract improves gastrointestinal discomfort in a randomized placebo controlled double blind human pilot study. BMC Complement Altern Med. 2014 May 27;14:173. doi: 10.1186/1472-6882-14-173. |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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|
| 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. | 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. | 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. | reported at days with stool during 4 week intervention |