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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046621
Receipt No. R000053184
Scientific Title Verification of the usefulness of food material intake for iron-related indicators in adult women -Randomized double-blind parallel group comparison method-
Date of disclosure of the study information 2022/01/14
Last modified on 2022/01/13

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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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