none
Conditions
Interventions
Ingestion of supplement for twenty-four weeks.
Ingestion of placebo for twenty-four weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged 50 to 70 years. 2)Subjects who are evaluating body mass index 25 to 30. 3) Subjects who are feeling disorder of stool form including chronic hard stool or loose stool. 4) Subjects who received a sufficient explanation about the purpose and content of this study and have a consent ability and volunteered to participate in the understanding and can agree to this study participation in writing.
Exclusion criteria
Exclusion criteria: 1) Subjects who use medicine that may influence a bowel movement. 2) Subjects who take health food or dietary supplement that may influence a bowel movement. 3) Subjects who take general food including Bifidbacterium that continue more than three times a week and more than half year. 4) Subjects who take medicine, Kampo preparation or dietary supplement affecting weight reduction. 5) Subjects who have colonic disease within 10 years, but these persons except who polyp or infectious colitis. 6) Subjects who take medical treatment for obesity-related disease that is glucose intolerance, dyslipidemia, hypertension, hyperuricemia, gout, coronary artery disease, cerebral infarction, fatty liver, menstrual abnormality, sleep apnea syndrome?obesity hypoventilation syndrome, orthopedic disease, obesity-related renal disease. 7) Subjects who have severe disorders in liver function or kidney function. 8) Subjects who have history of gastrointestine surgery that is gastrectomy, gastrointestinal suture, enterectomy, etc. 9) Subjects who have allergy to medicine, shrimp, crab, milk or egg. 10) Subjects who can't discontinue dietary supplements for test period. 11) Subjects who are planned to participate in other clinical study. 12) Female with pregnancies, lactating or planning to become pregnant during the study. 13) Subjects whom metal is implanted in a CT scanning part by operation treatment. 14) Subjects whom heart pacemaker or implantable cardiac defibrillator is implanted in own body. 15) Subjects who have extreme constipation or diarrhea. 16) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visceral Fat Area(VFA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Weight, BMI, Subcutaneous fat area(SFA), Total fat area(TFA), Stool frequency, Bristol stool from scale(BSFS) | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed