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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name