UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049793 |
|---|---|
| Receipt number | R000056669 |
| Scientific Title | Examination of changes in blood hormone levels due to intake of test food -Single-arm open study- |
| Date of disclosure of the study information | 2022/12/16 |
| Last modified on | 2023/08/28 09:18:27 |
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Basic information
Public title
Examination of changes in blood hormone levels due to intake of test food
Acronym
Examination of changes in blood hormone levels due to intake of test food
Scientific Title
Examination of changes in blood hormone levels due to intake of test food
-Single-arm open study-
Scientific Title:Acronym
Examination of changes in blood hormone levels due to intake of test food
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine changes in blood hormone levels during the menstrual cycle by ingesting RP-001 continuously for 90 days in healthy women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood hormone levels
Key secondary outcomes
sex hormones
oxidation marker
MDQ
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
Ingestion of test food for 90 days
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
| 25 | years-old | <= |
Age-upper limit
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Healthy female subjects aged between 25and 42 years at the time of informed consent
(2) Subjects with a stable menstrual cycle
(3) Subjects whose blood AMH is 0.5 ng/mL or more and less than 3.0 ng/mL
(4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria
(1) Subjects with heart, liver, or kidney disease (including complications of other diseases)
(2) Subjects with a history of cardiovascular disease
(3) Subjects with diabetes
(4) Subjects who suffer from diseases that may affect the results of the study, or who are undergoing treatment
(5) Subjects with food and drug allergies
(6) Subjects with symptoms of anemia that interfere with daily life
(7) Female subjects who wish to become pregnant, who are pregnant (including those who may be pregnant), or who are breastfeeding while participating in this study
(8) Subjects using female sex hormones, pyrroloquinoline quinone, coenzyme Q10
(9) Subjects who participate in strenuous sports and who are on a diet
(10) Subjects with extremely irregular eating habits
(11) Subjects who consume more than 60 g of pure alcohol per day
(12) Subjects with a smoking habit
(13) Subjects with a BMI of 30 or higher
(14) Subjects participating in or planning to participate in other clinical trials at the start of this study
(15) Subjects who are otherwise judged by the principal investigator or subinvestigator to be unsuitable for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Aoyagi |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science Business Planning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo
TEL
0368326013
aoyagi@rohto.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
530-0044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
ROHTO Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical 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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
06-6135-5200
mterashima@miura-cl.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
医療法人花音会みうらクリニック（大阪府） Miura Clinic, Medical Corporation Kanonkai（Osaka）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 16 | 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
| 2022 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056669
