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
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
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
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
