UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030815 |
|---|---|
| Receipt number | R000035182 |
| Scientific Title | Influence of heat-killed Lactococcus lactis H61 on iron status: a randomized double-blind, parallel-group, placebo-controlled trial |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2018/03/27 14:10:30 |
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Basic information
Public title
Influence of heat-killed Lactococcus lactis H61 on iron status: a randomized double-blind, parallel-group, placebo-controlled trial
Acronym
Influence of heat-killed Lactococcus lactis H61 on iron status
Scientific Title
Influence of heat-killed Lactococcus lactis H61 on iron status: a randomized double-blind, parallel-group, placebo-controlled trial
Scientific Title:Acronym
Influence of heat-killed Lactococcus lactis H61 on iron status
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of heat-killed Lactococcus lactis H61 on iron status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
hemoglobin, ferritin, transferrin saturation
Pre and Post intake (4 weeks)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of heat-killed Lactococcus lactis H61 for 4 weeks
Interventions/Control_2
Intake of placebo for 4 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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy female, aged 18 to 25 years.
2. Subjects in good physical condition such that they can perform testing safely.
3. Subjects who have given voluntary, written, informed consent to participate in the study.
Key exclusion criteria
1. Subjects suffering from serious cardiovascular disorder, liver function disorder, renal dysfunction, respiratory disorder, endocrine disorder, metabolic disorder, or those having history of them
2. Subjects with history of chest pain or fainting.
3. Subjects who are likely to cause allergies related to the test supplement
4. Subjects who donated 200 mL within 1 month prior to the start of the study, or 400 mL (blood donation etc.) within 3 months
5. Smokers
6. Subjects who are judged as unsuitable for this study by physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
Address
1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL
+81-476-98-1001
yssuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
Address
1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL
+81-476-98-1001
Homepage URL
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Health and Sports Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
順天堂大学さくらキャンパス（千葉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 15 | 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
| 2017 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 15 | Day |
Last modified on
| 2018 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035182
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
