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
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
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
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
