UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000022773
Receipt No. R000026204
Scientific Title research on nutritional beverage for exercise stress
Date of disclosure of the study information 2016/08/31
Last modified on 2019/12/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title research on nutritional beverage for exercise stress
Acronym research on nutritional beverage for exercise stress
Scientific Title research on nutritional beverage for exercise stress
Scientific Title:Acronym research on nutritional beverage for exercise stress
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of beverage on mental and physical conditions under chronic stress
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate effects of beverage ingestion on mental and physical conditions at 6 and 12 weeks into intervention by Stress-related Questionnaire and measurement items
Key secondary outcomes Questionnaire on nutritional status and 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
18 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 taking medication at least for three months prior to the enrollment and during the experimental period.
3. Persons having milk and soy bean allergies.
Target sample size 50

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
Email 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
Email knishida@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

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
Email 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 Published

Result
URL related to results and publications https://doi.org/10.1016/j.jff.2019.04.022
Number of participants that the trial has enrolled 49
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 Main results already published
Date of protocol fixation
2016 Year 08 Month 30 Day
Date of IRB
2016 Year 07 Month 25 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2019 Year 05 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
2016 Year 06 Month 17 Day
Last modified on
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026204

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.