UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the usefulness of food material intake for iron-related indicators in adult women
Acronym	Verification of the usefulness of food material intake for iron-related indicators in adult women
Scientific Title	Verification of the usefulness of food material intake for iron-related indicators in adult women -Randomized double-blind parallel group comparison method-
Scientific Title:Acronym	Verification of the usefulness of food material intake for iron-related indicators in adult women -Randomized double-blind parallel group comparison method-
Region	Japan

Condition
Condition	Healthy adult female
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines the effects of test food intake on the iron-related index
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum iron concentration
Key secondary outcomes	Blood hemoglobin concentration Serum ferritin concentration Unsaturated iron binding capacity Total iron binding capacity Indefinite complaint questionnaire Dietary survey

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Take 2 capsules daily for 6 weeks containing iron and iron deficiency improving materials
Interventions/Control_2	Take 2 capsules daily for 6 weeks containing iron
Interventions/Control_3	Take 2 capsules daily for 6 weeks that do not contain iron nor iron deficiency improving materials
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	20 years-old <=
Age-upper limit	39 years-old >=
Gender	Female
Key inclusion criteria	Healthy women aged 20 to 39 on the date of consent. Subjects who can input electronic diaries using PCs, smartphones, etc. Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to consent, have well understood, volunteered to participate, and have signed the informed consent document.
Key exclusion criteria	Subjects who are being treated for anemia. Subjects who are judged by the study responsibility doctor to be treated for anemia by comprehensively judging from the blood index at the time of screening test. Subjects who regularly use health foods such as supplements. Subjects who have a habit of strenuous exercise that induces hemolytic anemia. Subjects who drink a lot of alcohol (60g or more / day). Subjects who have a smoking habit (Subjects less than 1 year after quitting smoking). Subjects who are losing or increasing weight excessively. Subjects who are pregnant or breast-feeding, or planning to be pregnant during the test period. Subjects who participated in tests that use other foods and pharmaceuticals, tests that apply cosmetics and pharmaceuticals, etc. within 1 month from the time of obtaining consent, and subjects who participate in other tests while participating in this study. Subjects who donated 200 mL or more of blood (including whole blood and ingredient.s) from 4 months before the screening test Subjects who may change their lifestyle such as long-term travel during the examination period. Subjects who have experienced illness or illness due to blood sampling in the past. Subjects who are judged as unsuitable for the study because of the menstrual disorders or etc. by the investigators.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Murakami
Organization	Ajinomoto Co., Inc.
Division name	Functional Ingredients Development Group, Institute of Food Sciences and Technologies
Zip code	210-8681
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-210-5844
Email	hitoshi.murakami.vf4@asv.ajinomoto.com

Public contact
Name of contact person	1st name Ryo Middle name Last name Uchida
Organization	Ajinomoto Co., Inc.
Division name	Functional Ingredients Development Group, Institute of Food Sciences and Technologies
Zip code	210-8681
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-210-5844
Homepage URL
Email	ryo.uchida.xs6@asv.ajinomoto.com

Sponsor
Institute	IMEQRD Co., Ltd.
Institute
Department

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	Suda Clinic institutional review board
Address	2-8-14 takadanobaba, sinjuku-ku, Tokyo
Tel	03-6704-5968
Email	n-yuzawa@imeqrd.co.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	医療法人社団　浩央会　東小金井さくらクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 14 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	2021 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date	2022 Year 01 Month 15 Day
Last follow-up date	2022 Year 04 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 13 Day
Last modified on	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053184

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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