UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019450 |
|---|---|
| Receipt number | R000022406 |
| Scientific Title | A Randomized, Double-blind, Placebo-Controlled, Parallel Group Comparison Study on the Effects of Daily Ingestion of Isoflavone -Rich Soybean, "Yukipirika" on the Improvement of Bone Metabolism and Menopausal Symptoms |
| Date of disclosure of the study information | 2015/10/23 |
| Last modified on | 2017/10/10 08:52:06 |
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Basic information
Public title
A Randomized, Double-blind, Placebo-Controlled, Parallel Group Comparison Study on the Effects of Daily Ingestion of Isoflavone -Rich Soybean, "Yukipirika" on the Improvement of Bone Metabolism and Menopausal Symptoms
Acronym
The Effect of Daily Ingestion of the Soybean on the Improvement of Bone Metabolism and Menopausal Symptoms
Scientific Title
A Randomized, Double-blind, Placebo-Controlled, Parallel Group Comparison Study on the Effects of Daily Ingestion of Isoflavone -Rich Soybean, "Yukipirika" on the Improvement of Bone Metabolism and Menopausal Symptoms
Scientific Title:Acronym
The Effect of Daily Ingestion of the Soybean on the Improvement of Bone Metabolism and Menopausal Symptoms
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove clinical benefits of daily ingestion of isoflavone -rich soybean, "Yukipirika" on bone metabolism and menopausal symptoms for 8 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Simplified Menopausal Index, urinary NTx, urinary DPyr, serum TRACP-5b at 4 and 8 weeks after ingestion of test meals.
Key secondary outcomes
TC,LDL-C,HDL-C,TG, arteriosclerosis index, E2, FSH,TIBC,UIBC, conditions of skin and hair, functions of joints, VAS scores of bowel movements, BW,BMI and BFR
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of 8.5g of "Yukipirika" soybean flakes daily for 8 weeks.
Interventions/Control_2
Ingestion of 8.5g of "Fukuyutaka" soybean flakes daily for 8 weeks.
Interventions/Control_3
Ingestion of 8.5g of wheat flakes daily for 8 weeks.
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 have subjective symptoms of menopause.
2. Subjects whose serum TRACP-5b is >=309 mU/dl and <=760mU/dl.
3. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria
1. Subjects who are under treatment and medication for menopausal symptoms, osteoporosis and thyroid disease.
2. Subjects who are under treatment and medication for psychiatric disorders.
3. Subjects who are considered to have secondary osteoporosis (due to endocrine disorders, continuous use of steroids, etc.).
4. Subjects whose urinary productivity of equol is low.
5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, or gastrointestinal diseases, or affected with infectious diseases which are required to report to the authorities.
6. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
7. Subjects with unusually high and/or low blood pressure or abnormal hematological data.
8. Subjects with serious anemia.
9. Subjects who are at risk of having allergic reactions to drugs or foods (especially soybean and wheat).
10. Subjects who regularly take medicine, functional foods and/or supplements (isoflavone, daidzein, genistein, glycitein, equol, pycnogeno, onion, maca, etc.) which would improve menopausal symptoms.
11. Subjects who regularly take medicine, functional foods and/or supplements (isoflavone, calcium, magnesium, CBP, MBP, vitamin D, etc.) which would affect the bone metabolism.
12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle
13. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
14. Subjects who participate in other clinical trials within the last one month prior to the this study.
15. Any other medical reasons judged by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Center of Health Information Science
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Northern Advancement Center for Science & Technology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ffhdj.com/index.php/ffhd/article/view/359
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
Main results already published
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 13 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 20 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022406
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