UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037780
Receipt number R000043084
Scientific Title A study for the effect of intake of test foods on mood status
Date of disclosure of the study information 2020/12/20
Last modified on 2023/07/20 15:08:06

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Basic information

Public title

A study for the effect of intake of test foods on mood status

Acronym

A study for the effect of intake of test foods on mood status

Scientific Title

A study for the effect of intake of test foods on mood status

Scientific Title:Acronym

A study for the effect of intake of test foods on mood status

Region

Japan


Condition

Condition

None (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of intake of test foods on mood status

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Tests for mood status

Key secondary outcomes

Measurements of microbiome
Saliva analysis
Questionnaires
blood pressure


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


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of test tablets, 6 tablets a day, 6 weeks

Interventions/Control_2

Intake of placebo tablets, 6 tablets a day, 6 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

45 years-old <=

Age-upper limit

64 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Men and women aged from 45 to 64
2)Subjects whose primary language is Japanese
3)Subjects who often feel irritation or anxiety in daily life
4)Subjects who do not exhibit depression symptoms assessed in Beck Depression Inventory II (scored under 19)
5) Subjects with inferior results of questionnaires

Key exclusion criteria

Subjects
1)who regularly take drugs, supplements, or foods which richly contain the components of test food or components similar to test food at least once a week
2)who regularly take drugs or foods which may affect and/or who regularly perform activities to treat their mood, fatigue, stress, and sleep, at least once a week
3)who have irregular working days
4)who have irregular lifestyles during the study, or who work manual labor
5)who are planning to change their lifestyles largely
6)who regularly drink too much alcohol
7)who have been diagnosed or suspected as psychological disorders
8)who suffer from sleep related diseases, or are conscious of it
9)who have been diagnosed as chronic fatigue syndrome
10)who may have allergy to test foods
11)who may have physical deconditioning due to test foods
12)who have taken antibiotics within 3 months before fecal sampling
13)whose feces are unsuitable for fecal sampling
14)who regularly smoke or who started smoking cessation within 12 months
15)who have been diagnosed as dry mouth
16)who had treatment for tooth or mouth within 1 month, or who are planning to have those treatment during this study
17)who have troubles in the mouth
18)who bleed in the mouth when brushing their teeth at least once a week
19)who have done blood transfusion or blood donation within 3 months
20)who have participated in other clinical studies within 1 month, or who are planning to participate in other clinical studies during this study
21)who have diseases requiring regular administration, or have severe diseases
22)who are judged as unsuitable by doctor for laboratory value, anthropometric measurements, or physical examination value
23)who are, or are planning to be pregnant or breastfeeding during study
24)who are judged as unsuitable due to lifestyle questionnaire
25)who or whose family work in a company developing or manufacturing functional foods
26)who are judged as unsuitable by doctor for other reasons

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Kuniaki
Middle name
Last name Obara

Organization

Kirin Holdings Company, Limited

Division name

Research & Development division, Research Laboratories for Health Science & Food Technologies

Zip code

236-0004

Address

1-13-5, Fukuura Kanazawa-ku, Yokohama, Japan

TEL

080-1930-9932

Email

k-obara@kirin.co.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Nakagawa

Organization

TTC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

t.nakagawa@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Kirin Holdings Company, Limited

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

Aisei Hospital Ueno Clinic Research Ethics Committee

Address

2-18-6, Higashiueno, Taitou-ku, Tokyo

Tel

03-6455-0880

Email

t.saito@ttc-smo.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

2020 Year 12 Month 20 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

2019 Year 08 Month 22 Day

Date of IRB

2019 Year 08 Month 22 Day

Anticipated trial start date

2019 Year 08 Month 29 Day

Last follow-up date

2019 Year 12 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 23 Day

Last modified on

2023 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043084


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name