UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of isoflavone metabolism and intestinal bacterial flora by taking fermented soy milk beverages
Title of the study (Brief title)	Isoflavone metabolism by taking fermeted soy milk
Region	Japan

Condition
Condition	Haelthy women
Classification by specialty	Medicine in general Gastroenterology Endocrinology and Metabolism Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate isoflavone metabolizm by taking fermented soy milk beverages, we evaluate urinary isoflavone metabolites,intestinal flora and life event.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	urinary isoflavone metabolites.
Key secondary outcomes	intestinal flora life event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration:8weeks test beverage:fermented soy milk. Frequency:Drink it twice a day after breakfast and dinner Volime:200ml(100ml*2)
Interventions/Control_2	Duration:8weeks placebo beverage:fermented soy milk. Frequency:Drink it twice a day after breakfast and dinner Volime:200ml(100ml*2)
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	18 years-old <=
Age-upper limit	55 years-old >=
Gender	Female
Key inclusion criteria	1)Persons whose ages are ranging from 18 to 55 years old female 2)Person who can spend nomal condetion during test duration. 3)In case of the person who have mild life-style reratied disease,It is possible to join the discretion of the investigator.
Key exclusion criteria	1)Person who have severe disease (liver disease, kidney disease,heart disease and so on)or Food allergy,or Durg allergy. 2)Person who could not drink soy milk. 3)Person who have soy or soy milk or milk allergy. 4)Person who take antibiotic while the test duration. 5)Person often use some Laxaytive or some spplemants for costipation resolved. 6)Person who have severe costipation disease. 7)pregnate woman 8)Person who is rejected the participating of this study by chief investigater.
Target sample size	60

Research contact person
Name of lead principal investigator	Akira Tanaka
Organization	kagawa Nutrition Universit
Division name	Nutrition Clinic
Address	3-24-3 Komagome Tosima-ku,Tokyo
TEL	03-3918-6181
Email	clinic@eiyo.ac.jp

Public contact
Name of contact person	Keiko Kamachi
Organization	Kagawa Nutrition University
Division name	Nutrition Clinic
Address	3-24-3 Komagome
TEL	03-3918-6181
Homepage URL
Email	clnic@eiyo.ac.jp

Sponsor
Institute	Kagawa Nutrition University
Institute
Department

Funding Source
Organization	Yakult Honsha 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)

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	女子栄養大学　栄養クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 16 Day
Anticipated trial start date	2014 Year 09 Month 28 Day
Last follow-up date	2015 Year 01 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 17 Day
Last modified on	2016 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018848