Effect of Daily Ingestion of Lactulose on Bone Density in Healthy Postmenopausal Women: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000053646
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 150
Not provided
1.Subjects with serious cancer, respiratory, hepatic, renal, cardiac, lung, gastrointestinal, blood, endocrine, metabolism diseases, and/or have serious medical history those disease. 2.Subjects with gastrointestinal disorders such as irritable bowel syndrome or inflammatory bowel disease. 3.Subjects with major surgical history relevant to the digestive system. 4.Subjects who regularly take medicine which would affect intestinal environment and/or bone metabolism. 5.Subjects who cannot abstain from taking functional foods (food for specified health uses, foods with function claims, foods with nutrient function claims) which affect intestinal environment, bone metabolism, and/or bone density, supplements which contain vitamin D3 and/or mineral. 6.Subjects who are at risk of having allergic reactions to drugs or foods, especially milk. 7.Subjects with lactose intolerance. 8.Subjects with a history of lumbar spine or hip surgery, and/or who have metal plates on their lumbar spine and/or hip. 9.Subjects who use pacemakers and/or defibrillators. 10.Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 11.Subjects whose BMI is >=30 kg/m2. 12.Subjects who are ineligible due to physician's judgment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone mineral density (lumbar spine, left femur)
- Secondary Outcome Measures
Name Time Method Blood bone metabolism markers : Bone-type alkaline phosphatase (BAP), Tartate-resistant acid phosphatase-5b (TRACP-5b), Total procollagen type 1 -N-propeptide (t-P1NP), undercarboxylated osteocalcin (ucOC) Urinary bone metabolism markers: Deoxypyridinoline (DPD), Type I collagen cross-linked N-telopeptides (NTX) Organic acids in blood faecal microbiota