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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048699


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name