UMIN-CTR Clinical Trial

Basic information
Public title	Chrono-nutritional intervention using a food-log based health App
Acronym	Chrono-nutritional intervention using a food-log based health App
Scientific Title	Chrono-nutritional intervention using a food-log based health App
Scientific Title:Acronym	Chrono-nutritional intervention using a food-log based health App
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To understand the effect of the chrono-nutritional intervention on the bodyweight change in the App users.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Food log, sleep parameters, physical activity, personality, depression score, health score, bodyweight, BMI, body fat percentage, step counts
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	For the intervention, users of this App are asked those 4 contents during the next 1 month. 1. reduce the duration of food intake to less than 12 hours. 2. reduce carbohydrates intake at dinner. 3. balance the food amount in each breakfast, lunch, and dinner for 3:3:3. 4. try to record food log at leat 3 days per a week. Users are asked to answer the surveys before and after the intervention.
Interventions/Control_2	For the control group, we ask surveys twice and ask to use this App for a month.
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	We divided two groups randomly at first, then the half of users are asked to join the intervention group, and another half are asked to join the control group.
Key exclusion criteria	Subjects who drop out to use this App or record logs for less than 3 days/week.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Shigenobu Middle name Last name Shibata
Organization	Waseda University
Division name	Faculty of Science and Engineering
Zip code	1620056
Address	Wakamatsu-cho 2-2, Shinjuku-ku, Tokyo
TEL	03-5369-7318
Email	shibatas@waseda.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Tahara
Organization	Waseda University
Division name	Faculty of Science and Engineering
Zip code	1620056
Address	Wakamatsu-cho 2-2, Shinjuku-ku, Tokyo
TEL	03-5369-7318
Homepage URL
Email	yutahara0829@gmail.com

Sponsor
Institute	Waseda University
Institute
Department

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

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

IRB Contact (For public release)
Organization	Waseda University
Address	Tozuka-cho 1-104, Shinjuku-ku, Tokyo
Tel	03-5272-1639
Email	rinri@list.waseda.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	2021 Year 01 Month 24 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	Completed
Date of protocol fixation	2021 Year 01 Month 18 Day
Date of IRB	2020 Year 06 Month 01 Day
Anticipated trial start date	2021 Year 01 Month 25 Day
Last follow-up date	2021 Year 05 Month 05 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 01 Month 19 Day
Last modified on	2022 Year 02 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049152