UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
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	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Center of Health Information Science
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 09 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ffhdj.com/index.php/ffhd/article/view/359
Results
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