UMIN-CTR Clinical Trial

Basic information
Public title	Effect of iron-containing food intake on metabolism for iron
Acronym	Effect of iron-containing food intake on metabolism for iron
Scientific Title	Effect of iron-containing food intake on metabolism for iron
Scientific Title:Acronym	Effect of iron-containing food intake on metabolism for iron
Region	Japan

Condition
Condition	Healthy women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Purpose of this clinical test are the effect of the test food, iron derived from beans, on the recovery of iron levels after menstruation, and to assess the usefulness and safety of iron derived from beans.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in hemoglobin before and after intervention
Key secondary outcomes	Ferritin, red blood cells, serum iron, serum zinc, serum copper, hematocrit, TIBC, MCH, MCHC, anemia symptoms questionnaire, OSA sleep questionnaire, anti-fatigue questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of foods containing pea-derived ferritin iron
Interventions/Control_2	Intake of Placebo
Interventions/Control_3
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	60 years-old >=
Gender	Female
Key inclusion criteria	(1) Women who experience iron deficiency on a daily basis (anemia symptoms) (2) Premenopausal women (3) Women with a BMI of less than 30 kg/m2 (4)Those whose menstruation is in a designated cycle (within 1 week of the end of menstruation on July 28 and 29: follicular phase, end of menstruation on August 3 and 4 or within 3 days of the end of menstruation) (5)Those whose menstrual cycle is relatively stable (6)Those who can voluntarily consent to participate in the study in writing (7) Patients who have had a hemoglobin level of less than 13 g/dL (preferably less than 12 g/dL) in a previous blood test
Key exclusion criteria	(1) Those who are allergic to beans (soybeans, peas, and other legumes in general) (2) Those who are currently on medication for iron deficiency anemia. (3) Those who are currently receiving medication for any disease. (4) Those who are taking the food (soy milk) or health food containing the ingredients of this test food (5) Those with irregular menstrual cycles (6) Persons with serious diseases of glucose metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system, or mental disorders. (6) Those who have a history of serious diseases or mental disorders, and those who have a history of such diseases. (7) Those who have abnormal clinical laboratory values and are judged to have a problem with participation in the study. (8) Those who have a disease under treatment or a history of serious disease requiring medication. (9) Those who may develop allergies related to the study. (10)Those who are judged to be unsuitable as subjects based on the results of the answers to the lifestyle questionnaire. (11)Those who are participating in other clinical research at the time of the start of this study. (12) Those who are pregnant or plan to become pregnant or breastfeed during the study period (13) Patients with uterine fibroids or endometriosis (14)Those who are judged by the principal investigator to be unsuitable for participation in the study.
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Yujji Middle name Last name Kuriyama
Organization	Juntendo University School of Medicine
Division name	Department of General Medicine
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421 Japan
TEL	03-3813-311
Email	kuri@a2-pro.com

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Otake
Organization	feileB Co.Ltd
Division name	Clinical Trial Session
Zip code	160-0015
Address	7th Floor Gran-First Shinjyuku-Gyoen Bldg, 22-1 Daikyo-cho, Shinjyuku-ku, Tokyo 160-0015, Japan
TEL	03-6416-4228
Homepage URL
Email	otake@feileb.jp

Sponsor
Institute	Anti-Aging Pro Corporation
Institute
Department

Funding Source
Organization	Anti-Aging Pro Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tsukiji Futaba Clinic institutional review board
Address	Hosokawa-Tsukiji Build. 6F, Tsukiji 1-9-9, Cyuou-ku, Tokyo
Tel	03-6226-5812
Email	tohru@hikobae.net

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

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 24 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 07 Month 19 Day
Date of IRB	2021 Year 07 Month 20 Day
Anticipated trial start date	2021 Year 08 Month 25 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 08 Month 24 Day
Last modified on	2022 Year 02 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051693