UMIN-CTR Clinical Trial

Public title

Trial for reduction of anxiety and fatigue -open study-

Acronym

Trial for reduction of anxiety and fatigue

Scientific Title

Trial for reduction of anxiety and fatigue -open study-

Scientific Title:Acronym

Trial for reduction of anxiety and fatigue

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effects of ingesting the test food for 4 weeks on anxiety and fatigue in women aged between 50 and 65 years.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

fatigue
VAS score(anxiety fatigue)
QOL questionnaire (behavior changes)
Sleep questionnaire (SMH)

Key secondary outcomes

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

Take 2 tablets of test food with water twice a day

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

50

years-old

<=

Age-upper limit

65

years-old

>

Gender

Female

Key inclusion criteria

1. Aged 20 to under 65 at the time of informed consent.
2. Japanese females.
3. Those who are menopausal.
4. Those who do not need treatment but have anxiety of fatigue.
5. Those who feel more anxious than last year.
6. Those who can input electronic diary with smartphone / PC.
7. Those who understand the contents of the study and obtain written consent before the test based on the person's free will.

Key exclusion criteria

Subjects who
1. are currently receiving any types of medicines and/or Chinese medical treatment (except for the drugs taken as needed).
2. plan to change their lifestyle during the test.
3. have a serious illness such as liver, kidney, heart, respiratory tract, endocrine, metabolic disease, etc..
4. are receiving treatment for mental illness such as depression or anxiety disorder, or have a history of it.
5. May take sleeping pills/ sleep-inducing drugs during the test period, continuously or when they need.
6. Have been diagnosed with chronic fatigue syndrome.
7. Have had life events that affect their mind and body such as loss of important things within one month (death of relatives, loss of employment, divorce, pet death).
8. Take healthy foods or supplements daily. (acceptable if they can stop taking after obtaining consent.)
9. have a past and current medical history of drug or food allergy.
10. have participated in other clinical trials within one month before obtaining consent, or those who plan to participate during the trial period.
11. consume alcohol excessively (alcohol equivalent 60g or more / day).
12. have smoking habit.
13. have an irregular diet, or irregular life rhythms (work in shifts, work late at night etc.).
14. are judged by the investigator to be unsuitable for participating in this study.

Target sample size

20

Name of lead principal investigator

1st name	Kiyoshi
Middle name
Last name	Nakamura

Organization

Kunitachi Sakura Hospital

Division name

Chairman

Zip code

186-0002

Address

1-19-10 Higashi, Kunitachi-shi, Tokyo

TEL

042-577-1011

Email

higashikoganeisakura-clinic@imeq.co.jp

Name of contact person

1st name	Yoshitada
Middle name
Last name	Hira

Organization

IMEQRD inc.

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo

TEL

03-6704-5968

Homepage URL

Email

y-hira@imeqrd.co.jp

Institute

IMEQRD inc.

Institute

Department

Personal name

Organization

Integrate co., ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjyuku,Tokyo

Tel

03-3207-8161

Email

suda-clinic_irb@imeq.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

01

Month

13

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

2020

Year

12

Month

11

Day

Date of IRB

2020

Year

12

Month

17

Day

Anticipated trial start date

2021

Year

01

Month

14

Day

Last follow-up date

2021

Year

03

Month

02

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

01

Month

06

Day

Last modified on

2021

Year

04

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049001