UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046621 |
|---|---|
| Receipt number | 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 | 2022/07/15 11:21:55 |
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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
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
ryo.uchida.xs6@asv.ajinomoto.com
Sponsor or person
Institute
IMEQRD Co., Ltd.
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
Suda Clinic institutional review board
Address
2-8-14 takadanobaba, sinjuku-ku, Tokyo
Tel
03-6704-5968
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 06 | Day |
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 | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053184
