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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033331
Receipt No. R000037994
Scientific Title Study on intestinal environment and nutritional status in university students.
Date of disclosure of the study information 2018/07/17
Last modified on 2019/01/15

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Basic information
Public title Study on intestinal environment and nutritional status in university students.
Acronym Study on intestinal environment in university students.
Scientific Title Study on intestinal environment and nutritional status in university students.
Scientific Title:Acronym Study on intestinal environment in university students.
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationships between intestinal environment and nutritional status in healthy subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between intestinal environment(16S rRNA gene-based metagenome analysis of gut microbiome and intestinal metabolites) and nutritional status (anthropometric data, body composition, muscle strength and diet record)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Subjects who have given written informed consent
2)Subjects who have participated in the study "Effects of long-term ingestion of protein-rich milk on muscle strength in university students"(UMIN000027032)
Key exclusion criteria Subjects who are judged as ineligible by the lead study conductor
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Okaya Eiji
Organization Meiji Co., Ltd.
Division name Food science & Technology Research Laboratories, R&D Division
Zip code
Address 1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN
TEL 042-632-5849
Email eiji.okaya@meiji.com

Public contact
Name of contact person
1st name
Middle name
Last name Yamaguchi Makoto
Organization Meiji Co., Ltd.
Division name Food science & Technology Research Laboratories, R&D Division
Zip code
Address 1-29-1 Nanakuni, Hachiouji, Tokyo, JAPAN
TEL 042-632-5849
Homepage URL
Email makoto.yamaguchi@meiji.com

Sponsor
Institute Meiji Co., Ltd
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 株式会社 明治 研究本部/ R&D Division, Meiji Co., Ltd.

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 17 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 07 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 07 Month 09 Day
Last modified on
2019 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037994

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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