UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042677 |
|---|---|
| Receipt number | R000048699 |
| Scientific Title | Validation of cooking-based ICT dietary assessment system using the doubly labeled water method in Ehime. |
| Date of disclosure of the study information | 2021/02/28 |
| Last modified on | 2022/01/31 22:45:14 |
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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
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
maruyama.kotatsu.rt@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048699
