Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Supplement containing Lactococcus lactis subsp. cremoris Flora aid (50 mg) Administration: Take one capsule per day with water *If you forget to take the test food
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose defecation frequency is three to five times per week 6. Subjects whose defecation frequency is few in seven days prior to Scr
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who have lactose intolerance 5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 6. Subjects who use or take medicines, "Foods for Specified Health Uses," or "Foods with Functional Claims" with intestinal regulating effects in daily 7. Subjects who are currently taking medications (including herbal medicines) and supplements 8. Subjects who are allergic to medicines and/or the test food related products 9. Subjects who have a smoking habit 10. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 12. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of defecation frequency in period V* *Period V: 22~28 days after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The defecation frequency in period II, III, and IV* 2. The numbers of defecation days and amount of defecation in period II, III, IV, and V* 3. Each state of stool shape, stool smell, and exhilarating feeling of defecation in period II, III, IV, and V* 4. The score of the Constipation Assessment Scale Middle Term version (CAS-MT), subjective fatigue, and "sleepiness on rising", "initiation and maintenance of sleep", "frequent dreaming", "refreshing" and "sleep length" in the OSA sleep inventory MA version (OSA-MA) at two and four weeks after consumption (2w, 4w). 5. The occupancy rate of bacteria in the stool, the diversity index, mucin in the stool, immunoglobulin A (IgA) in the stool, the stool pH, organic acid levels (acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, and formic acid) in the stool, salivary cortisol, and the serotonin in the blood at 4w 6. Each item of CAS-MT and the OSA-MA at 2w and 4w *Period I: The seven days prior the screening (before consumption; Scr) Period II: The seven days after initial consumption Period III: 8~14 days after consumption Period IV: 15~21 days after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed