Abdominal Pain/ Discomfort, Slightly Constipation
Conditions
Keywords
Gastrointestinal discomfort, Perilla frutescens, bloating, abdominal discomfort, human study, healthy subjects
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTPerilla extract
DIETARY_SUPPLEMENTMaltodextrin
Sponsors
Amino Up Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| daily gastrointestinal symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| validated questionnaires | 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. 1. Patient assessment of constipation symptoms (PAC SYM) 2. Patents assessment of constipation quality of life (PAC QOL) 3. Perceived stress questionnaire (PSQ20) |
| stool consistency | 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. |
| Adverse events | 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. |
| Stool frequency | reported at days with stool during 4 week intervention | The stool frequency was reported on each day with bowel movement. |
Countries
Germany
Outcome results
None listed