Confirmatory study of the effect of ingestion of food containing seaweed extract on the intestinal environment
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000042578
- Lead Sponsor
- HUMA R&D CORP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 32
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stool test (intestinal flora)
- Secondary Outcome Measures
Name Time Method (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