Healthy adults
Conditions
Interventions
Take the test food for 4 consecutive weeks.
Take the control food for 4 consecutive weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy males and females who are aged 20-64 years at the time of obtaining consent 2)Subjects who defecate 3-5 times a week at the point of screening test 3)Subjects who have received a sufficient explanation of the purpose and content of the study, have the consent ability and good understandings, and have agreed voluntarily in writing to participate in the study
Exclusion criteria
Exclusion criteria: Subjects (who) 1)regularly take bowel medicines and laxatives 2)regularly take health foods that are known to improve constipation at the time of screening test 3)take drugs that affect digestion and absorption for 2 weeks prior to the screening test 4)cannot stop taking food for specified health uses, with functional claims, with nutrient function claims and supplements during the study period 5)with serious diseases such as malignant tumours,or with a serious history of these diseases 6)with allergies to food ingredients in the test food 7)habitually take excessive amounts of alcohol (maximum daily amount: equivalent to 20.1 g pure alcohol equivalent or more and at least 4 days a week) or who are unable to abstain from alcohol during the designated period 8)with a smoking habit 9)suffering from a disease requiring urgent treatment or with serious complications 10)with a history of digestive disorders or surgery affecting digestion, absorption or defecation (excluding adenoidectomy, appendicitis, etc.) 11)are pregnant, wish to become pregnant during the study period, or breast-feeding 12)with a history or current history of drug or alcohol dependence 13)work shifts or late nights 14)with an extremely irregular diet 15)plan to go abroad during the study period 16)plan to transfer or move during the study period 17)can only go to the toilet at set times during the study period due to work or other reasons 18)with a weight fluctuation of more than plus or minus 5 kg within 2 months prior to the start of the screening test 19)have had a blood collection or component blood donation of more than 200 mL within 1 month of the screening test or 400 mL within 3 months prior to the screening test 20)have participated or wish to participate in trials involving the ingestion of other foods or the use of drugs, or the application of cosmetics and drugs, within 3 months before the date of obtaining consent 21)are judged unsuitable as a subject by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of defecation | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation status Intestinal environment Indicators related to glucose metabolism and liver function Questionnaire on physical condition and mood | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed