UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030975 |
|---|---|
| Receipt number | R000032988 |
| Scientific Title | Relationship between equol producer status and intestinal microflora and effects of supplementation with equol and lactobionic acid on metabolic and bone parameters in healthy postmenopausal women |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2020/02/19 11:46:03 |
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Basic information
Public title
Relationship between equol producer status and intestinal microflora and effects of supplementation with equol and lactobionic acid on metabolic and bone parameters in healthy postmenopausal women
Acronym
Relationship between equol producer status and intestinal microflora and effects of supplementation with equol and lactobionic acid on metabolic and bone parameters in healthy postmenopausal women
Scientific Title
Relationship between equol producer status and intestinal microflora and effects of supplementation with equol and lactobionic acid on metabolic and bone parameters in healthy postmenopausal women
Scientific Title:Acronym
Relationship between equol producer status and intestinal microflora and effects of supplementation with equol and lactobionic acid on metabolic and bone parameters in healthy postmenopausal women
Region
| Japan |
Condition
Condition
Healthy postmenopausal women
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between dietary factors and types of microflora as well as equol producer status.
To examine the effects of supplementation with equol and lactobionic acid on the risk factors of lifestyle related diseases such as arteriosclerosis and visceral fat accumulation, as well as markers related to bone metabolism, and compare those in relations to the background characteristics mentioned above.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparisons from baseline in the results of blood lipids (TG, HDL-C, LDL-C, T-CL), uric acid, hemoglobin A1c, arterial stiffness (baPWV), visceral fat area, and markers related to bone metabolism (vitamin D, PTH) after supplementation with equol and lactobionic acid for 12 weeks as well as comparisons based on background characteristics
Key secondary outcomes
Cor-relations between advanced glycation end products, dietary factors and equol producer status as well as types of microflora
Comparison from baseline in the results of menopausal rating scale after supplementation with equol and lactobionic acid every four weeks
Monitoring of adverse effects of supplementation every four weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
30 women taking 3 capsules of equol(total dose
of 10 mg) and lactobionic acid daily for 12 weeks
Interventions/Control_2
30 women not taking the above supplementation
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
-Healthy postmenopausal (primary) women aged 50 years and above
-Those undergoing medical checkup at Sendai medical Center
-Those who can come to the clinic every month since the beginning of the study to have interview or investigations
-Those who can take the supplementation daily and take daily notes throughout the study period (12 weeks)
Key exclusion criteria
-Those with history of allergy to soy foods, dairy products or Brewer's yeast
-Those who start taking medications or functional food that could affect the result of the study
-Those under hormone replacement therapy or medications that could affect the blood hormone level
-Others identified inappropriate by the investigator physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Ishigaki |
Organization
Shinkokai Medical Corporation
Division name
Sendai General Health Screening Clinic
Zip code
980-0811
Address
Sendai Trust Tower 4F, 1-9-1 Ichiban-cho, Aoba-ku, Sendai-shi, Miyagi prefecture
TEL
022-722-3770
yoko.ishigaki@shinkokai.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Kato |
Organization
Shinkokai Medical Corporation
Division name
Sendai General Health Screening Clinic
Zip code
980-0811
Address
Sendai Trust Tower 4F, 1-9-1 Ichiban-cho, Aoba-ku, Sendai-shi, Miyagi prefecture
TEL
022-722-3770
Homepage URL
megumi.kato@shinkokai.jp
Sponsor or person
Institute
Supplement department, Advanced Medical Care Inc.
Institute
Department
Personal name
Funding Source
Organization
Supplement department, Advanced Medical Care Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hamamatsucho Hamasite Clinic, Midtown Clinic Medical Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinkokai Medical Corporation
Address
SVAX Nishi-shinnbashi Building, 2-39-3 Nishi-shinbashi, Minato-ku, Tokyo
Tel
03-5408-8181
chie.nakajima@shinkokai.jp
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
せんだい総合健診クリニック（宮城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/30188331
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30188331
Number of participants that the trial has enrolled
60
Results
Women receiving equol supplement showed improved arterial stiffness and climacteric symptoms. Significant improvement in skin auto-fluorescence and visceral fat area was observed in equol producers.
Almost all participants have equol producing bacteria, however, there are only 20% of equol producers. Equol producing ability is related to gut microflora diversity.
Results date posted
| 2020 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
48 to 69 years of age
Postmenopausal women (natural absence of menstruation over at least 12 months since the last menstrual period or a bilateral oophorectomy procedure performed in a woman (surgical menopause)
Those who could visit the clinic every month for interviews or investigations during the study period
Those who could remain compliant with the daily supplementation regimen and record daily notes throughout the study period comprising 12 weeks
Participant flow
Recruitment
Enrollment
Baseline study
Intervention and follow-up monthly
Completion
Adverse events
There has been no adverse events reported due to equol supplement intervention.
There is no case who needs to stop taking the supplement.
Outcome measures
Inter-relationships between diets, gut microbiome and equol producing ability
Changes in metabolic and aging biomarkers after three months
Changes in menopausal symptoms after three months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Equol production might not depend on the quantity, but on the quality of equol-producing bacteria. High microbial diversity might enhance equol production. Increasing microbial diversity through healthy lifestyle habits and habitual consumption of a wide variety of foods might be useful to maintain a healthy gut environment for equol production.
Management information
Registered date
| 2018 | Year | 01 | Month | 24 | Day |
Last modified on
| 2020 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032988
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| Registered date | File name |
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