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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
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 | 2022/07/15 |
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- |
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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- |
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Region |
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Condition | ||
Condition | Healthy adult female | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 45 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |