UMIN-CTR Clinical Trial

Basic information
Public title	Survey on dietary choices aimed at raising health awareness: a parallel group-to-group comparative study
Acronym	Survey on dietary choices aimed at raising health awareness: a parallel group-to-group comparative study
Scientific Title	Survey on dietary choices aimed at raising health awareness: a parallel group-to-group comparative study
Scientific Title:Acronym	Survey on dietary choices aimed at raising health awareness: a parallel group-to-group comparative study
Region	Japan

Condition
Condition	healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to conduct an introduction test of the TLF label with the nutrition label affixed to the front of the food packaging and to verify its practicality when used for long periods in young people.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Compare dietary choices between the TLF-labeled and non-TLF-labeled groups for a week.
Key secondary outcomes	1) Compare the increase and decrease in the number of people who are conscious of a healthy diet in the TLF label use group and the non-use group. 2) Evaluate which of the nutritional components that should be noted for overdose will become conscious in the TLF label use group and the non-use group. (Calorie, fat, saturated fatty acid, sugar, salt, etc.) 3) Evaluate whether there is a difference in how stress is felt between the TLF label use group and the non-use group.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Intervention group: Select a meal once a day with the nutrition label (TLF label) when choosing a meal at dinner (for seven consecutive days)
Interventions/Control_2	Control group. Select a meal once a day at dinner without nutrition labeling (TLF labeling) (7 consecutive days)
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	18 years-old <=
Age-upper limit	30 years-old >
Gender	Male and Female
Key inclusion criteria	Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
Key exclusion criteria	Key exclusion criteria: 1) refuse to participate in the study; 2) Those who have dietary restrictions as a result of metabolic or endocrine disorders 3) People with eating disorders 4) Those who have anorexia 5) Those who have intentionally or unintentionally gained or lost weight by more than 5% in the past 3 months 6) are deemed ineligible by principal investigator for other reasons not listed above.
Target sample size	68

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Wakui
Organization	Hoshi University
Division name	Division of Applied Pharmaceutical Education and Research
Zip code	142-8501
Address	2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL	03-5498-5760
Email	n-wakui@hoshi.ac.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Wakui
Organization	Hoshi University
Division name	Division of Applied Pharmaceutical Education and Research
Zip code	142-8501
Address	2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL	03-5498-5760
Homepage URL
Email	n-wakui@hoshi.ac.jp

Sponsor
Institute	Hoshi University
Institute
Department

Funding Source
Organization	Hoshi University
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	Hoshi University Research Ethics Committee
Address	142-8501, 2-4-41 Ebara, Shinagawa-ku, Tokyo
Tel	03-3786-1011
Email	somu@hoshi.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	2022 Year 03 Month 23 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	2022 Year 03 Month 16 Day
Date of IRB	2022 Year 03 Month 16 Day
Anticipated trial start date	2022 Year 03 Month 24 Day
Last follow-up date	2022 Year 05 Month 16 Day
Date of closure to data entry	2022 Year 05 Month 16 Day
Date trial data considered complete	2022 Year 05 Month 16 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 23 Day
Last modified on	2022 Year 05 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053895