UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of exercise and functional milk on nutritional iron status and body composition in young females
Title of the study (Brief title)	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	Kazuhiro Uenishi
Organization	Kagawa Nutrition University
Division name	Physiological Nutrition
Address	3-9-21,Chiyoda,Sakado,Saitama 350-0288 JAPAN
TEL	049-284-3895
Email	uenishi@eiyo.ac.jp

Public contact
Name of contact person	Kazuhiro Uenishi
Organization	Kagawa Nutrition University
Division name	Physiological Nutrition
Address	3-9-21,Chiyoda,Sakado,Saitama 350-0288 JAPAN
TEL	049-284-3895
Homepage URL
Email	uenishi@eiyo.ac.jp

Sponsor
Institute	Kagawa Nutrition University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 09 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022594