UMIN-CTR Clinical Trial

Basic information
Public title	A confirmation test of the influence for hemoglobin level by consumption of the food which contain lactic acid bacteria
Acronym	A confirmation test of the influence for hemoglobin level by consumption of the food which contain lactic acid bacteria
Scientific Title	A confirmation test of the influence for hemoglobin level by consumption of the food which contain lactic acid bacteria
Scientific Title:Acronym	A confirmation test of the influence for hemoglobin level by consumption of the food which contain lactic acid bacteria
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To validate the influence for hemoglobin level by twelve weeks continuous consumption of the food containing lactic acid bacteria
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hemoglobin level
Key secondary outcomes	Serum ferritin level Mean corpuscular volume (MCV) Reticulocyte count Total iron binding capacity (TIBC) Red blood cells level (RBC) Mean corpuscular hemoglobin (MCH) Mean corpuscular hemoglobin concentration (MCHC) Hematocrit Serum iron level Serum folic acid level Serum vitamin B12 level Questionnaire of anemia subjective symptoms Questionnaire of QOL Incidence of adverse events and side effects

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake two tablets of test food a day, for twelve weeks.
Interventions/Control_2	Intake two tablets of control food a day, for twelve weeks.
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	59 years-old >=
Gender	Female
Key inclusion criteria	(1) Females who aged between 20 to 59 when informed consent. (2) Females whose hemoglobin levels at preliminary test are less than 12.0g/L and whose serum ferritin levels are 15ng/mL. (3) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria	(1) Females who are received medical treatment due to anemia symptom. (2) Females who have dysmenorrhea. (3) Females who menopaused. (4) Females who have extreme unbalanced diet. (5) Subjects who having medicine, quasi-drug, Food for Specified Health Uses (FOSHU), functional indication food, supplement and/or health food within three months before starting consumption of test food. (6) Subjects who have excess meal regulation, excess diet planning and /or excess irregular meal cycle. (7) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (8) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (9) Subjects who excessive alcohol intake. (10) Subjects who have previous medical history of drug and/or food allergy. (11) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (12) Subjects who are intolerant to lactose (13) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (14) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (15) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (16) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	ICHIBIKI CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel	03-5297-5548
Email	IRB@cpcc.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

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 17 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	2019 Year 07 Month 22 Day
Date of IRB	2019 Year 07 Month 19 Day
Anticipated trial start date	2019 Year 08 Month 17 Day
Last follow-up date	2019 Year 12 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 14 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042980