UMIN-ICDS Clinical Trial

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

healthy individuals

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

blood hormone levels

Key secondary outcomes

sex hormones
oxidation marker
MDQ

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

aoyagi@rohto.co.jp

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

Email

mterashima@oneness-sup.co.jp

Institute

ROHTO Pharmaceutical Co., Ltd.

Institute

Department

Personal name

Organization

ROHTO Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Email

mterashima@miura-cl.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2022

Year

12

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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/icdr_e/ctr_view.cgi?recptno=R000056669