Healthy adult
Conditions
Interventions
Pre-treatment observation period(1 week), treatment observation period, subject take the test food(4 weeks), post-treatment observation period(2 weeks)
Pre-treatment observation period(1 week), treatm
Sponsors
Other Pharma Foods International Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females, aged 20 - 65 years old with constipation tendency with defecation frequency 5 times or less per week. 2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: 1) Subjects who have medical history of malignant tumor, heart failure or myocardial infarction. 2) Subject receiving treatment for gastrointestinal diseases and constipation disease. 3) Currently undergoing treatment for or having a medical history with any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4) Subjects who frequently take medicines for intestinal disorder or laxatives 5) Subjects who frequently take medicines (including herbal medicines) 6) Subjects who are allergic to medicines and/or the test food related products. 7) Subjects with irregular life rhythms such as shift workers, irregular eating habits. 8) Subjects who are pregnant, breast-feeding, or planning to get pregnant. 9) Subjects who have been enrolled in other clinical trials. 10) Subjects who are considered as ineligible to participate in the study by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency, feeling after defecation, ease of defecation, amount, smell and color of feces, fecal condition (Measure at a daily basis for 1 week during the pre-treatment period, and in the week right before the 2nd, 4th and 6th week when the treatment started) Activity of NK cell and concentration of IgA in blood (Measure at before ingestion and after 4-week intake) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event(Inquiry consultation) Blood lipid maker (Measure at before ingestion and after 4-week intake) | — |
Countries
Japan
Contacts
Public ContactAkiko Ishida
Pharma Foods International Co., Ltd. Research and Development department
Outcome results
None listed