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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017190
Receipt No. R000018858
Scientific Title Plasma kinetics of the isoflavones daidzein and genistein after ingestion of fermented soy milk beverages in healthy women.
Date of disclosure of the study information 2015/04/20
Last modified on 2016/08/05

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Basic information
Public title Plasma kinetics of the isoflavones daidzein and genistein after ingestion of fermented soy milk beverages in healthy women.
Acronym Plasma kinetics of the isoflavones daidzein and genistein after ingestion of fermented soy milk.
Scientific Title Plasma kinetics of the isoflavones daidzein and genistein after ingestion of fermented soy milk beverages in healthy women.
Scientific Title:Acronym Plasma kinetics of the isoflavones daidzein and genistein after ingestion of fermented soy milk.
Region
Japan

Condition
Condition Healthy women
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We experiment with the blood metabolites measurement about fermented soy milk beverage, compared with soy milk beverage.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change over time of blood isoflavone metabolism product
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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 Prevention
Type of intervention
Food
Interventions/Control_1 The volunteers eat food without isofulavone and also go without foods from 9:00pm on the pre-test day.
We take the pre-test blood from volunteers on test day.
Then, the volunteers take test meal. Each 60,120,180,240,300 minutes later, we collect blood samples from them.
And after we collect 120 minutes after the test meal,we let them eat 2 rice bails for lunch.
On another day, we do crossover experiment.
Interventions/Control_2 The volunteers eat food without isofulavone and also go without foods from 9:00pm on the pre-test day.
We take the pre-test blood from volunteers on test day.
Then, the volunteers take placebo meal. Each 60,120,180,240,300 minutes later,
we collect blood samples from them.
And after we collect 120 minutes after the test meal,we let them eat 2 rice bails for lunch.
On another day, we do crossover experiment.
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 A woman with the menstruation.
The woman who is not infected with a serious disease.
The daily life which there is in a lifestyle constantly during testing period.
About the slight chronic disease, it is said that participation is possible by the judgment of the examination responsibility doctor.
Key exclusion criteria A serious disease, food, drug allergy, the one with the mental disease.
The person who cannot take soybean milk.
The person who takes the Chinese medicine including the kudzu constantly.
A pregnant or nursing woman and the person who hope for the pregnancy all over the study time.
The person who admitted that a doctor was inappropriate on carrying out other final examination.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tanaka
Organization Kagawa Nutrition University
Division name Nutrition Clinic
Zip code
Address 3-24-3 Kmagome Toshima-ku,Tokyo
TEL 03-3918-6181
Email clinic@eiyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Kamachi
Organization Kagawa Nutrition University
Division name Nutrition Clnic
Zip code
Address 3-24-3 Komagome Toshima-ku,Tokyo
TEL 0339186181
Homepage URL
Email clinic@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)

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 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 04 Month 20 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
Isoflavone related substances has increased significantly in the test group
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 Completed
Date of protocol fixation
2014 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 20 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=R000018858

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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