UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054736 |
|---|---|
| Receipt number | R000062515 |
| Scientific Title | A study of the effect of test-food on sex hormone production in middle-aged women |
| Date of disclosure of the study information | 2024/06/24 |
| Last modified on | 2024/12/24 12:51:17 |
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Basic information
Public title
A study of the effect of test-food on sex hormone production in middle-aged women
Acronym
A study of the effect of test-food on sex hormone production in middle-aged women
Scientific Title
A study of the effect of test-food on sex hormone production in middle-aged women
Scientific Title:Acronym
A study of the effect of test-food on sex hormone production in middle-aged women
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effects on sex hormone production and menopausal symptoms after supplementation with test-food for 4 weeks in middle-aged women feeling menopausal symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sex hormone testing and Simplified Menopause Index (SMI) (after 4 weeks intervention)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test-food (4 tablets) with (lukewarm) water, once daily after breakfast, for 4 weeks.
Interventions/Control_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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Age: from 40 to 69 years-old
2. Individuals who are healthy and are not received treatment of disease
3. Individual who are aware of menopausal symptoms (ex. fatigue, lethargy, anxiety, palpitation, or breathlessness )
4. Individuals whose written informed consent has been obtained
5. Individuals judged appropriate for the study by the principal
Key exclusion criteria
1. Individuals using medical products
2. Individuals with a history of mental illness, sleep apnoea, hypertension, diabetes, taste disorder, anaemia, dyslipidaemia or treatment for a serious illness in the past one year
3. Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
4. Individuals who are a patient or have a history of or endocrine disease
5. Individuals who use a drug to treat a disease in the past 1 month
6. Individuals who are sensitive to test product or other foods, and medical products
7. Individuals who have a habit of or have been in a habit of continuously consumption of health-promoting foods, health foods or supplements containing high levels of ingredients that have been implied to have effects similar to those of the test product within the past one month, or who plan ingest these products during the test period
8. Individuals who are pregnant or lactating, and females who could become pregnant or lactating during test period
9. Individuals who are participating the other clinical tests. Individuals who participated within 3-month prior to the current study
10. Individuals who are unable to come to the facility on the designated examination date
11. Individuals who do not comply with instructions from the doctor or medical staff
12. Individuals judged inappropriate for the study by the principal
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sekiguchi |
Organization
YOKOHAMA MOTOMACH, LUNA Woman Medical Clinic
Division name
CEO
Zip code
231-0861
Address
1-32, Motomachi, Naka-Ku, Yokohama, Kanagawa, Japan
TEL
045-651-6321
anna@luna-clinic.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Saito |
Organization
DKS Co. Ltd
Division name
Basic R and D Group, New Business Development Department, Life Sciences headquarters
Zip code
601-8391
Address
5, Ogawara-cho, Kisshoin, Minai-ku, Kyoto, Japan
TEL
075-326-7572
Homepage URL
d.saito@dks-web.co.jp
Sponsor or person
Institute
DKS Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
DKS Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5, Higashiueno, Taito-ku, Tokyo, Japan
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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
女性医療クリニックLUNA横浜元町
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062515
