None listed
Conditions
Interventions
Food containing plant extract, 4 weeks consumption. Wash out. Food not containing plant extract, 4 weeks consumption
Food not containing plant extract, 4 weeks consumption. Wash out. Food containing p
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy males and females aged 20 to 64 years-old (2)Subjects who defecate three to five a week (3)Subjects who do not habitually consume a large amounts of alcohol (4)Subjects who regularly eat three meals a day (5)Subjects who can make self-judgment and are voluntarily giving written informed consent
Exclusion criteria
Exclusion criteria: Subjects (who) (1)regularly use intestinal and constipation drugs (including laxatives) (2)contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease) (3)have been diagnosed irritable bowel syndrome or inflammatory bowel disease (4)are under treatment for or have a history of drug addiction and/or alcoholism (5)can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation (including Food for Specified Health Uses or Foods with Function Claims) and/or containing a large amount of sugar alcohol during this study (6)regularly eat foods containing lactic acid bacteria, bifidobacteria, and/or oligosaccharides to relieve constipation (7)used antibiotics within the last 2 weeks prior to the screening (8)have a history and/or a surgical history of digestive disease affecting digestion and absorption (9)have any food allergies (10)have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking more than 4 days a week (11)can't stop drinking from 2 days before each measurement (12)are shiftworker and/or midnight-shift worker (13) declare that their menstrual cycle is disturbed (14)plan to become pregnant after informed consent, pregnant or lactating (15)have donated over 200 mL of blood and/or blood components within the last 1 month or over 400 mL of blood and/or blood components within the last 3 months prior to the study (16)plan to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month. (17)are judged unsuitable for the study by the screening (18)are judged unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| States of bowel movements Intestinal environment | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed