UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044950 |
|---|---|
| Receipt number | R000051353 |
| Scientific Title | Preliminary study for utilization of ultra-processed foods based on issues of nutrient intakes. |
| Date of disclosure of the study information | 2021/07/25 |
| Last modified on | 2022/04/01 21:43:33 |
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Basic information
Public title
Preliminary study for utilization of ultra-processed foods based on issues of nutrient intakes.
Acronym
Ultra-processed foods and issues of nutrient intake.
Scientific Title
Preliminary study for utilization of ultra-processed foods based on issues of nutrient intakes.
Scientific Title:Acronym
Association between ultra-processed foods and salt intake.
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine consider if the UPF diet is a diet with more energy and salt than the dish cooked at home, even if it is the same dish.
To examine consider if whether the UPF nutrient composition problem is solved by selecting and combining UPF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary sodium excretion
Key secondary outcomes
Urinary sodium-to-potassium ratio,
Body weight
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Replace usual diet with a meal consisting of ultra-processed foods for lunch or dinner.
Have them devise the desired use of ultra-processed foods and have them eat for lunch and dinner.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
3rd to 4th grade female college students majoring in nutrition
Key exclusion criteria
Those who have allergies
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Takemi |
Organization
Kagawa Nutrition University
Division name
Nutrition Ecology
Zip code
350-0288
Address
3-9-21 Chiyoda Sakado Saitama
TEL
049-282-3721
takemi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Koiwai |
Organization
Kagawa Nutrition University
Division name
Public health nutrition
Zip code
350-0288
Address
3-9-21 Chiyoda Sakado Saitama
TEL
049-283-9092
Homepage URL
koiwai.kaori@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Institute of Nutrition Sciences, Kagawa Nutrition University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Kagawa Nutrition University
Address
3-9-21 Chiyoda Sakado Saitama
Tel
049-282-1353
kenshien@eiyo.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
女子栄養大学（埼玉県）/ Kagawa Nutrition University（Saitama Pref.）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 25 | 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
16
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 | 06 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051353
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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