UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022810 |
|---|---|
| Receipt number | R000026252 |
| Scientific Title | Research on nutritional beverage for improvement in nutrition |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2019/12/02 17:15:25 |
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Basic information
Public title
Research on nutritional beverage for improvement in nutrition
Acronym
Research on nutritional beverage for improvement in nutrition
Scientific Title
Research on nutritional beverage for improvement in nutrition
Scientific Title:Acronym
Research on nutritional beverage for improvement in nutrition
Region
| Japan |
Condition
Condition
Healthy adults without major problems in psychological and physical health.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of beverage on improvement in nutrition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate effects of beverage ingestion on nutritional status at 8 and 12 weeks into intervention by Questionnaire and measurement items
Key secondary outcomes
Questionnaire on physical capabilities and measurement items of physical capabilities and nutrition
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
Daily intakes of beverage including LAB for 12 weeks
Interventions/Control_2
Daily intakes of beverage without LAB for 12 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects are without major problems in psychological and physical health.
Key exclusion criteria
1. Persons having history of psychiatric or somatic diseases in the past and present.
2. Persons having milk and soy bean allergies.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuhito |
| Middle name | |
| Last name | Rokutan |
Organization
Tokushima University
Division name
Dept. of Pathophysiology, Inst. of Biomedical Sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9004
rokutan@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensei |
| Middle name | |
| Last name | Nishida |
Organization
Tokushima University
Division name
Dept. of Pathophysiology, Inst. of Biomedical Sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9004
Homepage URL
knishida@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings, 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
Clinical Trial Center For Development Therapeutics
Address
2-50-1 Kuramotocho, Tokushima city
Tel
088-633-9294
awachiken@tokushima-u.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
| 2016 | Year | 08 | Month | 31 | 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
| 2016 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2019 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026252
