UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037688
Receipt number R000042980
Scientific Title A confirmation test of the influence for hemoglobin level by consumption of the food which contain lactic acid bacteria
Date of disclosure of the study information 2020/08/17
Last modified on 2020/10/09 11:54:26

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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 or person

Institute

CPCC Company Limited

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042980


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name