UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053646 |
|---|---|
| Receipt number | R000061152 |
| Scientific Title | Effect of Daily Ingestion of Lactulose on Bone Density in Healthy Postmenopausal Women: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study. |
| Date of disclosure of the study information | 2024/02/25 |
| Last modified on | 2024/02/09 19:26:06 |
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Basic information
Public title
Effect of Daily Ingestion of Lactulose on Bone Density in Healthy Postmenopausal Women: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Acronym
Effect of Daily Ingestion of Lactulose on Bone Density in Healthy Postmenopause Women.
Scientific Title
Effect of Daily Ingestion of Lactulose on Bone Density in Healthy Postmenopausal Women: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Scientific Title:Acronym
Effect of Daily Ingestion of Lactulose on Bone Density in Healthy Postmenopausal Women.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the clinical benefits of lactulose intake on bone density associated with 48 weeks in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density (lumbar spine, left femur)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion of lactulose and milk calcium for 48 weeks.
Interventions/Control_2
Daily ingestion of glucose and milk calcium for 48 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2 . Japanese women who have been postmenopausal for more than 1 year.
3. Subjects whose T-score is >-2.5 and <-1.0.
Key exclusion criteria
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.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061152
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