UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056725 |
|---|---|
| Receipt number | R000064836 |
| Scientific Title | Verification of the Effectiveness of Chrononutrition-Based Interventions for Promoting the Habit of Eating Breakfast. |
| Date of disclosure of the study information | 2025/01/16 |
| Last modified on | 2025/01/15 18:57:47 |
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Basic information
Public title
Verification of the Effectiveness of Educational Methods to Promote the Habit of Eating Breakfast.
Acronym
Verification of the Effectiveness of Educational Methods to Promote the Habit of Eating Breakfast.
Scientific Title
Verification of the Effectiveness of Chrononutrition-Based Interventions for Promoting the Habit of Eating Breakfast.
Scientific Title:Acronym
Verification of the Effectiveness of Chrononutrition-Based Interventions for Promoting the Habit of Eating Breakfast.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of chrononutrition-based interventions in promoting the habit of eating breakfast.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of Eating Breakfast.
Frequency of Soup Consumption at Breakfast.
Key secondary outcomes
Subjective mental and physical condition.
Contents of breakfast.
Subjective breakfast habits and consciousness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the on-site survey, answer a questionnaire.
Interventions/Control_2
Educational methods group
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Men and women between the ages of 18 and 39.
(2)Those who prepare their own breakfast.
(3)Those who eat breakfast several times a week.
(4)Those who want to eat breakfast more frequently.
(5)Those who cook for themselves.
(6)Those who agree to participate in on-site surveys and follow-up surveys during the study period and to record their breakfast and daily life.
(7)Those who fully understand the research participation and have given their own voluntary written consent.
Key exclusion criteria
(1)Those working night shifts (working between the hours of 22:00 and 5:00 the next morning)
(2)Those who work in the manufacturing industry(beverage/food),wholesale industry,retail industry,mass media industry,advertising industry,media industry,research industry, consulting industry,medical care,or pharmaceutical industry.
(3)Those who currently have some kind of food allergy.
(4)Those with dietary restrictions.
(5)Those who are pregnant or may become pregnant.
(6)Those who have resistance or concerns about eating instant soups(made by pouring hot water)or retort soups(heated in a microwave oven).
(7)Persons other than those listed above who are deemed unsuitable as subjects for this study by the research director.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Furuta |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
080-1038-6962
chie.furuta.cj3@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Gakuro |
| Middle name | |
| Last name | Ikeda |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
080-7738-2916
Homepage URL
gakuro.ikeda.y3u@asv.ajinomoto.com
Sponsor or person
Institute
Cross Marketing Inc.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
AJINOMOTO INSTITUTIONAL REVIEW BOARD
Address
15-1, Kyobashi 1-chome, Chuo-ku, Tokyo, Japan
Tel
03-5250-8111
ajinomoto_irb@asv.ajinomoto.com
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
| 2025 | Year | 01 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 15 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064836
