Double-blind, parallel-group, placebo-controlled study to compare a four 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-UMIN000014256
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1.Subjects who are suffering from serious cerebrovascular disease, heart disease, liver disease, renal disease, gastrointestinal disease or any infectious disease which needs immediate reporting. 2.Subjects with a clinical history of gastrointestinal cancer or are currently under its medical treatment. 3.Subjects having a clinical history of gastrectomy, gastrointestinal suture, bowel resection or any major surgery in the digestive system. 4.Subjects having a gastrointestinal disorder, irritable bowel syndrome, inflammatory bowel syndrome etc. 5.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.) 6.Subjects who will undergo dental treatment during this study period. 7.Subjects with frequent complaints of post-menopausal symptoms. 8.Subjects with unusually high and/or low blood pressure, or with abnormal hematological data. 9.Subjects with serious anemia. 10.Subjects with a history of allergy to medicine and food (especially mushroom). 11.Subjects who have defecation frequency less than four times per week or those who suffer from diarrhea. 12.Subjects who are heavy smokers or alcoholics, or exhibit irregular pattern in their lifestyles such as meals or sleep etc. 13.Subject who has donated 400ml whole blood within past 12 weeks or 200ml within past 4 weeks or who has donated plasma or platelets within past 2 weeks prior to this study. 14.Subjects who are pregnant or under lactation, or who expect to get pregnant during this study period. 15.Subject who has participated in other clinical trials within past one month or is currently undergoing any clinical trial. 16.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