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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029589
Receipt No. R000033747
Scientific Title Development of new sport foods and nutritional conditioning methods to prevent anemia and stress fracture of female athletes
Date of disclosure of the study information 2017/10/17
Last modified on 2019/04/19

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Basic information
Public title Development of new sport foods and nutritional conditioning methods to prevent anemia and stress fracture of female athletes
Acronym The effect of ingestion of functional foods on anemia and stress fracture
Scientific Title Development of new sport foods and nutritional conditioning methods to prevent anemia and stress fracture of female athletes
Scientific Title:Acronym The effect of ingestion of functional foods on anemia and stress fracture
Region
Japan

Condition
Condition anemia,osteoporosis
Classification by specialty
Medicine in general Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effect of ingesting functional foods containing inulin, calcium and iron on anemia and stress fracture in female athletes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Anemia index, bone mineral density, marker of bone metabolism, intestinal flora
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 Subjects consume a functional foods containing inulin, calcium and iron for from three to six months.
Interventions/Control_2
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
30 years-old >=
Gender Female
Key inclusion criteria 1)Subjects who are females of aged 18-30 years old
2)Subjects who can participate for about 6 months.
3)Subjects who obtain consent
4)Subjects whose training situation does not change
Key exclusion criteria 1)Subjects who take the medicine of metabolism, hormone, anemia and the osteoporosis
2)Subjects who cannot exercise by an injury
3)Subjects who are smoker
4)Subjects who are controlling own body weight
5)Subjects who are pregnant
6)Subjects who broke a bone during the past six months.
7)Subjects who judged that a doctor a is dangerous to participate in this study
8)Subjects who are participating another study
9)Subjects who have allergy related to the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoko Taguchi
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL 04-2947-6778
Email mtaguchi@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eri Takai
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL 04-2947-6778
Homepage URL
Email e-takai@aoni.waseda.jp

Sponsor
Institute Faculty of Sport Sciences,Waseda University
Institute
Department

Funding Source
Organization Japan Sports Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 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
2017 Year 07 Month 05 Day
Date of IRB
2017 Year 07 Month 05 Day
Anticipated trial start date
2017 Year 10 Month 02 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 17 Day
Last modified on
2019 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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