UMIN-CTR Clinical Trial

Basic information
Public title	The study of food intake and nutrition status of the inhabitants in Djibouti.
Acronym	The study of food intake and nutrition status of the inhabitants in Djibouti.
Scientific Title	The study of food intake and nutrition status of the inhabitants in Djibouti.
Scientific Title:Acronym	The study of food intake and nutrition status of the inhabitants in Djibouti.
Region	Africa

Condition
Condition	malnutrition
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to examine food intake and nutritional status of the inhabitants in Djibouti.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We examine the body weight and skeletal muscle such as nutritional states of inhabitant.
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	12 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The inhabitants fulfilling all of the following criteria were subjected to the survey. 1. Healthful persons 2. Inhabitants of either gender 3. Inhabitants who understood the purpose of experiment and signed a consent form
Key exclusion criteria	1. When the inhabitant does not agree to the experiment. 2. When the doctor determines that the survey is not medically or ethically adequate to the inhabitant.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Noriaki Middle name Last name Wakana
Organization	Tokyo university of agriculture
Division name	Faculty of applied biosciences, Department of nutritional science
Zip code	154-8502
Address	1-1-1, sakuragaoka, setagaya-ku, Tokyo
TEL	03-5477-2456
Email	n3wakana@nodai.ac.jp

Public contact
Name of contact person	1st name Noriaki Middle name Last name Wakana
Organization	Tokyo university of agriculture
Division name	Faculty of applied biosciences, Department of nutritional science
Zip code	154-8502
Address	1-1-1, sakuragaoka, setagaya-ku, Tokyo
TEL	03-5477-2456
Homepage URL
Email	n3wakana@nodai.ac.jp

Sponsor
Institute	Tokyo university of agriculture
Institute
Department

Funding Source
Organization	Tokyo university of agriculture
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	the Ethics Committee at the Tokyo University of Agriculture
Address	Sakuragaoka 1-1-1, Setagaya, Tokyo
Tel	03-5477-2456
Email	n3wakana-tua@umin.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	2020 Year 02 Month 18 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	2020 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date	2020 Year 02 Month 18 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	this study was observational study that examine food intake and nutritional status of inhabitants in Djibouti.

Management information
Registered date	2020 Year 01 Month 10 Day
Last modified on	2020 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044606