Open study to compare twelve week continuous ingestion effect of Champignon extract on fecal odor, body odor, oral odor and enteric environment of the subjects.
- Conditions
- Fecal odor, body odor, oral odor
- Registration Number
- JPRN-UMIN000014273
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
1. Subjects who are suffering from chronic diseases (such as cancer, liver disease, kidney disease, heart disease, gastrointestinal disorders, diabetes, dyslipidemia, hypertension, mental illness) or currently under its treatment. 2. Subjects who are suffering from serious cerebrovascular disease, heart disease, liver disease, renal disease, gastrointestinal disease or any infectious disease which needs immediate reporting. 3. Subjects having a clinical history of gastrectomy, gastrointestinal suture, bowel resection or any major surgery in the digestive system. 4. Subjects who will undergo dental treatment during this study period. 5. Subjects with frequent complaints of post-menopausal symptoms. 6. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data. 7. Subjects with serious anemia. 8. Subjects with a history of allergy to medicine and food (especially mushroom). 9. Subjects who have defecation frequency less than four times per week or those who suffer from diarrhea 10. Subjects under the medication for bowel movements (such as antibiotics, laxatives, medicine for constipation) or using functional foods and supplements (containing lactic acid bacteria, bifidobacterium, oligosaccharides, dietary fiber etc.) 11. Subjects who are heavy smokers or alcoholics, or exhibit irregular pattern in their lifestyles such as meals or sleep etc. 12. Subject who has donated 400ml whole blood within past 12 weeks or who has donated 200ml in past 4 weeks or plasma or platelets within past 2 weeks prior to this study. 13. Subjects who are pregnant or under lactation, or who expect to get pregnant during this study period. 14. Subject who has participated in other clinical trials within past one month or is currently undergoing any clinical trial. 15. Subjects who are judged ineligible by our physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fecal analysis (odor component, intestinal bacterial flora), fecal diary, VAS questionnaire for body odor, oral odor and bowel movement.
- Secondary Outcome Measures
Name Time Method atural killer cell activity, Lipid metabolism (T-Cho, TG, HDL-Cho, LDL-Cho), Blood glucose (fasting value, HbA1c), Blood analysis (WBC, RBC, Hb, Ht, Plt), Liver function (AST, ALT, gamma-GTP, ALP, LDH), Renal function (BUN, CRE, UA), vital signs (blood pressure, pulse rate), body composition (weight, BMI, fat percentage)