UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019538 |
|---|---|
| Receipt number | R000022594 |
| Scientific Title | Effects of exercise and functional milk on nutritional iron status and body composition in young females |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2017/09/28 10:05:21 |
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Basic information
Public title
Effects of exercise and functional milk on nutritional iron status and body composition in young females
Acronym
Effects of exercise and functional milk on nutritional iron status and body composition in young females
Scientific Title
Effects of exercise and functional milk on nutritional iron status and body composition in young females
Scientific Title:Acronym
Effects of exercise and functional milk on nutritional iron status and body composition in young females
Region
| Japan |
Condition
Condition
Anemia and iron deficiency
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement of the nutritional iron status
Basic objectives2
Others
Basic objectives -Others
Effects of exercise and functional milk on nutritional iron status in young females
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Hemoglobin levels after 12-week intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Vitamin and Iron, zinc-fortified drink(+)
Exercise(-)
Functional milk(-)
12-week
Interventions/Control_2
Vitamin and Iron, zinc-fortified drink(+)
Exercise(+)
Functional milk(-)
12-week
Interventions/Control_3
Vitamin and Iron, zinc-fortified drink(+)
Exercise(+)
Functional milk(+)
12-week
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
| 19 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Female
Key inclusion criteria
Low hemoglobin levels(below 12.5 mg/dL) or low ferritin levels(below 30 ng/ml)
Key exclusion criteria
Heavily patient
Ongoing patient
In pregnancy
Possibility of pregnancy
Food-allergic patient
Milk-allergic patient
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Uenishi |
Organization
Kagawa Nutrition University
Division name
Physiological Nutrition
Zip code
Address
3-9-21,Chiyoda,Sakado,Saitama 350-0288 JAPAN
TEL
049-284-3895
uenishi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Uenishi |
Organization
Kagawa Nutrition University
Division name
Physiological Nutrition
Zip code
Address
3-9-21,Chiyoda,Sakado,Saitama 350-0288 JAPAN
TEL
049-284-3895
Homepage URL
uenishi@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Meiji Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Co.,Ltd.
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
女子栄養大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 28 | 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
| 2015 | Year | 10 | Month | 28 | Day |
Last modified on
| 2017 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022594
| 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 |
