UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033838
Receipt number R000038594
Scientific Title A verification study of anemia improvement effect of the food containing lactic acid bacteria for females who have mild anemia symptom
Date of disclosure of the study information 2019/09/21
Last modified on 2019/11/06 18:05:39

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Basic information

Public title

A verification study of anemia improvement effect of the food containing lactic acid bacteria for females who have mild anemia symptom

Acronym

A verification study of anemia improvement effect of the food containing lactic acid bacteria

Scientific Title

A verification study of anemia improvement effect of the food containing lactic acid bacteria for females who have mild anemia symptom

Scientific Title:Acronym

A verification study of anemia improvement effect of the food containing lactic acid bacteria

Region

Japan


Condition

Condition

No applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the anemia improvement effect for the female who have mild anemia symptom by 8 weeks 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 concentration

Key secondary outcomes

Mean Corpuscular Volume (MCV)
Reticlocyte count
Serum ferritin concentration
Total iron binding capacity(TIBC)
Red blood cell
Mean Corpuscular hemoglobin(MCH)
Mean Corpuscular hemoglobin concentration (MCHV)
Hematocrit
Serum iron concentration
Folic acid concentration
Questionnaire of anemia subjective symptom


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

Consume two tablets of test food a day for eight weeks. Visit the clinic four weeks and eight weeks after starting consumption of the test food, then receive blood test and answer the questionnaire.

Interventions/Control_2

Consume two tablets of control food a day for eight weeks. Visit the clinic four weeks and eight weeks after starting consumption of the test food, then receive blood test and answer the questionnaire.

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) Healthy females aged 20 to 59 years old.
(2) Subjects who showed under 12.0g/dL of blood hemoglobin concentration and who are distinguished as mild anemia.
(3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

Key exclusion criteria

(1)Subjects who receive medical treatment of anemia.
(2)Subjects who are dysmenorrhea.
(3)Subjects who are after menopause.
(4)Subjects who have an excessive unbalanced diet.
(5)Subjects who have regularly used medicine, quasi-drugs, supplement and/or health food those concerned have an influence for the test, during 3 months before starting consumption of the test food.
(6) Subjects who conduct excess diet control and weight control, and/or who have irregular meal customs
(7)Subjects who are pregnant (including the possibility of pregnancy) or are lactating.
(8)Subjects who have severe past and/or current medical history in heart, liver, kidney and/or digestive organs.
(9) Subjects who are heavy drinkers of alcohol.
(10) Subjects who have allergy to medicine and/or food.
(11) Subjects who are participating, who have participated within 4 weeks and/or who plan to participate after informed consent of this test, in clinical test of other medicine or health food.
(12) Subjects who are lactose intolerance.
(13) Subjects who donated over 200mL blood and/or blood components within a month to the current study.
(14) Subjects who donated over 400mL blood within the last 4 months to the current study.
(15) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study.
(16) Others they have been determined ineligible by principal investigator or sub-investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Suguru
Middle name
Last name Fujiwara

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Chusin 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 Chusin 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)



IRB Contact (For public release)

Organization

Institutional review board of Chiyoda Paramedical Care Clinic

Address

2F Chusin 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

2019 Year 09 Month 21 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

20

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

2018 Year 07 Month 08 Day

Date of IRB

2018 Year 07 Month 05 Day

Anticipated trial start date

2018 Year 08 Month 21 Day

Last follow-up date

2019 Year 10 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 21 Day

Last modified on

2019 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038594


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name