UMIN-CTR Clinical Trial

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
Email	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
Email	koiwai.kaori@eiyo.ac.jp

Sponsor
Institute	Kagawa Nutrition University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051353