UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049042 |
|---|---|
| Receipt number | R000055793 |
| Scientific Title | A study of the effect of test food on the mental and physical condition. -randomized, placebo-controlled, double-blind, parallel-group trial- |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2022/09/27 18:57:52 |
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Basic information
Public title
A study of the effect of test food on the mental and physical condition. -randomized, placebo-controlled, double-blind, parallel-group trial-
Acronym
A study of the effect of test food on the mental and physical condition.
Scientific Title
A study of the effect of test food on the mental and physical condition. -randomized, placebo-controlled, double-blind, parallel-group trial-
Scientific Title:Acronym
A study of the effect of test food on the mental and physical condition.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to investigate the effect of 8 weeks intake of the test food on the mental and physical condition in healthy subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL questionnaire
intestinal microbiota
blood markers test
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
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take test food with water or warm water for 8 weeks.
Interventions/Control_2
Take placebo food with water or warm water 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Healthy subjects over 18 years old
2. Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose and made the written agreement Those who have no history of smoking within a year
Key exclusion criteria
1. Those who have been currently visiting a hospital or treated with any drug for any disease
2. Those who currently have or have history of severe diseases
3. Those who joined other clinical trials within 1 month before receiving informed consent in this study, or those who are currently joining other clinical trials
4. Those who are judged by the physician to be unsuitable for this study.
5. Those who are currently pregnant, breastfeeding or planning to get pregnant during the study period.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ozeki |
Organization
Taiyo Kagaku Co., Ltd
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichi, Mie 510-0844, Japan
TEL
059-347-5411
mozeki@taiyokagaku.co.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Abe |
Organization
Taiyo Kagaku Co., Ltd
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichi, Mie 510-0844, Japan
TEL
059-347-5411
Homepage URL
aabe@taiyokagaku.co.jp
Sponsor or person
Institute
Seitoku University
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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
Seitoku university ethics committee for human study
Address
550 Iwase, Matsudo-shi, Chiba, 271-8555, Japan
Tel
047-365-1111
ethics.committee@wa.seitoku.ac.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
| 2023 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 27 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055793
