Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy Japanese men and women aged between 20 and 60 at the time of obtaining written informed consent 2.Subject with constipation tendency (4 bowel movements / week or less, excluding severe constipation) 3.Subject who can record the questionnaire on the web during the test period 4.Subject who can come to the venue on the designated inspection date and undergo inspection 5.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing
Exclusion criteria
Exclusion criteria: 1.Subject with a history of comorbidities in the digestive organs (excluding a history of cecum) 2.Subject who is taking medication or under medical treatment 3.Subject who is under exercise therapy or dietetic therapy 4.Subject who may develop allergies due to the test foods and who may cause serious allergic symptoms to other foods and medicines 5.Subject with current or history of drug dependence or alcohol dependence 6.Heavy drinkers 7.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who have a history of mental illness in the past 8.Subject with irregular life rhythms due to night shifts or shift work 9.Subject with extremely irregular lifestyle habits such as eating and sleeping 10.Subject who has an extremely unbalanced diet 11.Subject who has difficulty in taking the full amount of the prescribed diet 12.Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have 13.Subject who uses health foods, supplements, and medicines that have an intestinal regulating effect 14.Subject who has participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period 15.Subject who has collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition 16.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating 17.Subject who has a smoking habit 18.Subject who has difficulty observing records on various survey forms 19.Subject who is judged as an inappropriate candidate according to the screening data 20.Subject who is considered as an inappropriate candidate by the doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool test (intestinal flora) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Defecation survey form (defecation frequency, feces, stool odor, stool color, stool volume, discomfort after defecation), stool tests(decay product content in feces, ammonia content in feces, stool odor stool short-chain fatty acid) (Safety evaluation) Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed