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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019450
Receipt No. 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

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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
Email 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
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022406

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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