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
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
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
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
