UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043966
Receipt number R000050219
Scientific Title Exploratory study on effects of plant extract-containing beverages against variations in a menopausal women's physical condition
Date of disclosure of the study information 2021/04/19
Last modified on 2022/04/27 14:18:53

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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 or person

Institute

CPCC Company Limited

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050219


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name