Healthy adults
Conditions
Interventions
Consumption of the test food (1 pack a day, 4 weeks) ->
Consumption of the placebo food (1 pack a day, 4 weeks)
Consumption of the placebo food (1 pack a day, 4 weeks) ->
Consumption of the test food (1 pack a day, 4 weeks)
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy subjects aged of 20-64 years 2) Subjects who defecate 3-5 times a week at the point of screening test 3) Subjects who have received sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate on good understanding, and have agreed to participate in the study in writing
Exclusion criteria
Exclusion criteria: 1) Subjects who have a history, current history or undergoing medical treatment of serious kidney disease, heart disease, respiratory disease, endocrine disease or diabetes 2) Subjects who have a chronic disease and regularly use medications 3) Subjects who diagnosed with chronic constipation 4) Subjects who have a digestive disease that affects digestion and absorption or defection, or a history of surgery (excluding appendicitis) 5) Subjects who have a history or current medical history of drug dependence or alcoholism 6) Subjects who plan to take medicines that affect the intestinal environment from the time of research application until the end of the study period 7) Subjects who are taking antibiotics or antibacterial agents, or who have taken them from the time of research application 8) Subjects who have consumed health foods or supplements that are known to improve constipation or affect the intestinal environment, 3 times a week or more at the time of the screening test 9) Subjects who have reported that they are allergic to the ingredient in test foods 10) Subjects who have a habit of drinking excessively 11) Subjects who have a habit of smoking excessively 12) Subjects who are pregnant, planning to become pregnant during this study or lactating 13) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month of informed consent 14) Subjects who plan to change their existing lifestyle, eating habits or living environment during the study period 15) Subjects who had one or less meals per day at least once a week during the month prior to application for the study 16) Subjects who have donated more than 200 mL of blood and/or component blood within one month or more than 400 mL within three months of consent in this study 17) Subjects who are restricting carbohydrates or dieting 18) Subjects who are judged as ineligible to participate in this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Defecation status 2) The Constipation Assessment Scale Middle Term version (CAS-MT) 3) Gut microbiota 4) Fecal organic acids content 5) Fecal putrefactive products content 6) Fecal ammonia content | — |
Countries
Japan
Contacts
Public ContactMasanori Numazu
KSO Corporation Clinical Trial Management department
Outcome results
None listed