UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study on effects of plant extract-containing beverages against variations in a menopausal women's physical condition
Acronym	Exploratory study on effects of plant extract-containing beverages against variations in a menopausal women's physical condition
Scientific Title	Exploratory study on effects of plant extract-containing beverages against variations in a menopausal women's physical condition
Scientific Title:Acronym	Exploratory study on effects of plant extract-containing beverages against variations in a menopausal women's physical condition
Region	Japan

Condition
Condition	none
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to exploratorily examine a healthy menopausal female subjects' characteristic with ingestion of a plant extract-containing beverage to the subjects continuously for approximately 8 weeks, by confirming the ingestion-deriving some kind of change in physical condition and mood of the female subjects, ranging in age from 40 to 60, who realize that the subjects themselves are in a state of fatigue feeling.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Score on Chalder fatigue scale 2. Mood state on short version of POMS2 3. The autonomic nervous activity level (High Frequency, Low Frequency) 4. The autonomic nervous system balance (LF / HF ratio)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test beverage (200 mL) to the subject, once a day for 8 weeks.
Interventions/Control_2	Oral ingestion of the placebo beverage (200 mL) to the subject, once a day for 8 weeks.
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	60 years-old >
Gender	Female
Key inclusion criteria	1) Subjects who can give informed consent to participate in this trial after being provided with an explanation of the experimental protocol detail. 2) Healthy female subjects ranging in age from 40 to 60 at informed consent. 3) At a point of the screening test, subjects who realize that the subjects themselves are in a steady state of fatigue feeling. 4) Subjects ranging in BMI from not less than 18.6 to less than 30.0 kg/m2. 5) Subjects who have an irregular menstrual period with not less than a week, or who have been amenorrhea for no more than 5 years.
Key exclusion criteria	1) Subjects with food allergy. 2) Subjects who have any difficulty in taking plant extract-containing foods (applicable to those who present symptoms of headache due to taste-related reasons and plant extract intakes). 3) Pregnant, possibly pregnant, or lactating subjects. 4) Subjects who have the habit of smoking, at the present time and/or within the past year before this trial. 5) Subjects with menopausal symptoms due to surgical treatments just like ovariectomy, and so on. 6) Subjects with serious or progressive chronic diseases/symptoms. 7) At a point of the screening test, subjects having infection history of COVID-19, and realizing that the subjects themselves are in the upward trend in fatigue feeling after the infection. 8) Subjects with a continuous remedy for chronic disease, accompanied by medication. 9) Subjects taking in the following foods that might affect menopausal symptoms; medicine (sleep inducers, antidepressants, antihypertensives, hormones, estrogen receptor-selective modulators for osteoporosis (SERMs), gynecological Chinese medicine), over-the-counter drugs (OTCs), health foods including health-specific/functional foods, with a frequency of no more than 5 days a week for over one month. 10) Subjects who took part in the other clinical/monitoring tests (limited to those involving oral intake or drug administration) within a month before giving informed consent to take part in this trial. 11) Others who have been determined as ineligible for participation in this trial, judging from the principal/sub investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shukuko Middle name Last name Ebihara
Organization	Chiyoda Paramedical Care Clinic
Division name	Director
Zip code	101-0047
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-5548
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Clinical Planning Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Meiji 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 19 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	2021 Year 03 Month 25 Day
Date of IRB	2021 Year 03 Month 19 Day
Anticipated trial start date	2021 Year 05 Month 20 Day
Last follow-up date	2021 Year 08 Month 19 Day
Date of closure to data entry	2021 Year 11 Month 24 Day
Date trial data considered complete	2021 Year 12 Month 01 Day
Date analysis concluded	2022 Year 04 Month 04 Day

Other
Other related information

Management information
Registered date	2021 Year 04 Month 19 Day
Last modified on	2022 Year 04 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050219