UMIN-CTR Clinical Trial

Basic information
Public title	Validation of cooking-based ICT dietary assessment system using the doubly labeled water method in Ehime.
Acronym	Validation of ICT dietary assessment system using the doubly labeled water method in Ehime.
Scientific Title	Validation of cooking-based ICT dietary assessment system using the doubly labeled water method in Ehime.
Scientific Title:Acronym	Validation of ICT dietary assessment system using the doubly labeled water method in Ehime.
Region	Japan

Condition
Condition	None.
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The double-labeled water method is a method for measuring the dynamics of energy in the body using stable isotopes and is internationally accepted. The objective of this study is to compare the ICT dietary assessment system with the double-labeled water method for estimating energy intake and to assess the validity.
Basic objectives2	Others
Basic objectives -Others	The secondary objective is to examine the association between nutrient intakes assessed by ICT dietary assessment system and the serum or urin biomarkers.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Dietary intakes.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Double labeled water is applied on day 1 of the study. Double labeled water contains more stable isotopes of oxygen and hydrogen than the natural abundance level, and 0.14 g of 18O and 0.06 g of 2H are applied per 1 kg of body weight.
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	40 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	Men and women aged 40 to 74 years live in Ehime Prefecture.
Key exclusion criteria	1. The persons who cannot visit the survey place twice (baseline and day 16). 2. The persons with diseases that affect energy metabolism (ex; thyroid disease, diabetes, etc.). 3. The persons with diseases or medication that affect water metabolism. 4. Using antihypertensive drug 5. Under 40 and over 75 years old 6. In the period of pregnancy and lactation 7. The persons who plan to stay outside the place of residence for at least 3 nights for 2 weeks before or during the intervention period. 8. The persons who have diet therapy or lose weight. 9. The persons who cannot be contacted by phone during the study period. 10. Menstruating on the first day of the study period. 11. The persons who are unsuited to participate the study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Koutatsu Middle name Last name Maruyama
Organization	Ehime University
Division name	Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department of Bioscience
Zip code	7908566
Address	3-5-7 Tarumi, Matsuyama, Ehime
TEL	089-946-9960
Email	maruyama.kotatsu.rt@ehime-u.ac.jp

Public contact
Name of contact person	1st name Koutatsu Middle name Last name Maruyama
Organization	Ehime University
Division name	Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department o
Zip code	7908566
Address	3-5-7 Tarumi, Matsuyama, Ehime
TEL	089-946-9960
Homepage URL
Email	maruyama.kotatsu.rt@ehime-u.ac.jp

Sponsor
Institute	Ehime University
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ehime University
Address	Shitsukawa, Toon, Ehime
Tel	089-960-5040
Email	rinri@m.ehime-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	愛媛大学、大洲市保健センター

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 28 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	2020 Year 01 Month 20 Day
Date of IRB	2020 Year 08 Month 25 Day
Anticipated trial start date	2021 Year 02 Month 27 Day
Last follow-up date	2022 Year 10 Month 01 Day
Date of closure to data entry	2022 Year 12 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2026 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 12 Month 07 Day
Last modified on	2022 Year 01 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048699