None
Conditions
Interventions
Intake of lactulose for 2 weeks
Intake of placebo for 2 weeks
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult males aged 20-64 years and adult females aged 45-64 years who were at least one year past menopause
Exclusion criteria
Exclusion criteria: 1)Subjects undergoing treatment for liver, kidney, heart, lung, gastrointestinal, hematological, endocrine, and infectious diseases, or those with a serious history of these diseases. 2)Subjects with a history of gastrointestinal resection (excluding appendicitis). 3)Subjects with gastrointestinal dysfunction such as irritable bowel syndrome or inflammatory bowel disease. 4)Subjects who regularly use medicine that affect the gut microbiota or bone metabolism (antibiotics, active biopharmaceuticals, laxatives, active vitamin D3, etc.) 5)Subjects who regularly use food with functional claims that improve the gut microbiota or maintain bone density or improve bone metabolism or promote mineral absorption, or foods containing vitamin D3 or mineral. 6)Subjects with serious allergies to medicines and food. 7)Subjects with lactose intolerance. 8)Subjects who participate in another clinical study within 3months before providing written consent to participate in the present study. 9)Subjects who are judged inappropriate for the study by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary mineral content | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiota | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed