UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035746 |
|---|---|
| Receipt number | R000040716 |
| Scientific Title | An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling |
| Date of disclosure of the study information | 2019/06/30 |
| Last modified on | 2019/02/01 17:08:41 |
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Basic information
Public title
An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling
Acronym
An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling
Scientific Title
An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling
Scientific Title:Acronym
An exploratory study on Anxiety-Improving Effect of Food Containing Lactic Acid Bacterium in Adults with anxious feeling
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate efficacy of food containing lactic acid bacterium for anxiety symptoms of adults with anxiety feeling in daily lives
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
-Depression Index
-Anxiety Index
Key secondary outcomes
-Anxiety Index
-Mood Index
-Intestinal Environment (Stool Frequency)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of the test food (8 weeks)
Interventions/Control_2
Intake of control food (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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Adult aged from 20 to 60 years old at time of informed consent was provided
Key exclusion criteria
1) Individuals with depression or who have diagnosed as a depression before
2) Individuals undergoing treatment for chronic disease
3) Individuals who have suicidal thoughts
4) Individuals who have allergy or who have history of sensitivity to the ingredients of test food
5) Individuals who are pregnant or nursing mother or individuals who are willing to become pregnant during this study
6) Individuals who participated in other clinical trials within 1 month
7) Individuals who intake medical chemicals or supplements that potentially influence the intestinal flora
8) Individuals who excessively take alcohol
9) Any Individuals considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamoru Hanyuuda |
Organization
Breast Health Clinic
Division name
Breast Health Clinic
Zip code
Address
3-8-10 Nihonbashi Kayabacho, Chuo-ku, Tokyo, Japan
TEL
03-6667-0345
imai@kt-medical.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Imai |
Organization
KT Medical Corporation
Division name
Food clinical trial Division
Zip code
Address
6F 2-2-3 Marunouchi,Chiyoda-ku, Tokyo, Japan
TEL
03-6667-0345
Homepage URL
imai@kt-medical.co.jp
Sponsor or person
Institute
KT Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
KAYABA-CHO MENTAL HEALTH CARE CLINIC
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
ブレストヘルスクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040716
