UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016250 |
|---|---|
| Receipt number | R000018848 |
| Scientific Title | Verification of isoflavone metabolism and intestinal bacterial flora by taking fermented soy milk beverages |
| Date of disclosure of the study information | 2015/01/17 |
| Last modified on | 2016/08/05 19:06:16 |
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Basic information
Public title
Verification of isoflavone metabolism and intestinal bacterial flora by taking fermented soy milk beverages
Acronym
Isoflavone metabolism by taking fermeted soy milk
Scientific Title
Verification of isoflavone metabolism and intestinal bacterial flora by taking fermented soy milk beverages
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Akira Tanaka |
Organization
kagawa Nutrition Universit
Division name
Nutrition Clinic
Zip code
Address
3-24-3 Komagome Tosima-ku,Tokyo
TEL
03-3918-6181
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 Clinic
Zip code
Address
3-24-3 Komagome
TEL
03-3918-6181
Homepage URL
clnic@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
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
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 |
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
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 | 09 | Month | 16 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018848
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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