UMIN-CTR Clinical Trial

Basic information
Public title	Effects of supplementary intake of milk protein and medium-chain triglyceride in combination with exercise training on body composition in female university students
Acronym	Effects of supplementary intake of milk protein and medium-chain triglyceride in combination with exercise training on body composition in female university students
Scientific Title	Effects of supplementary intake of milk protein and medium-chain triglyceride in combination with exercise training on body composition in female university students
Scientific Title:Acronym	Effects of supplementary intake of milk protein and medium-chain triglyceride in combination with exercise training on body composition in female university students
Region	Japan

Condition
Condition	Nomal
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of supplementary intake of milk protein and medium-chain triglyceride in combination with exercise training on body composition in female university students
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body composition
Key secondary outcomes	Quality of life

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	3
Purpose of intervention	Treatment
Type of intervention	Food Maneuver
Interventions/Control_1	Supplementary intake of placebo with exercise training for 12 weeks
Interventions/Control_2	Supplementary intake of milk protein and long-chain triglyceride in combination with exercise training for 12 weeks
Interventions/Control_3	Supplementary intake of milk protein and medium-chain triglyceride in combination with exercise training for 12 weeks
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	24 years-old >=
Gender	Female
Key inclusion criteria	Healthy female university students who have given written informed consent
Key exclusion criteria	Subjects 1)who have heart disease and/or respiratory disease and/or injury 2)who having take medicine 3)with food allergies (soybean, milk) 4)who having a smoking habit 5)who are judged as ineligible by the doctor for other reasons
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Michiyo Middle name Last name Kimura
Organization	Takasaki University of Health and Welfare
Division name	Faculty of Health and Welfare
Zip code	370-0033
Address	37-1 Nakaorui,Takasaki city,Gunma
TEL	027-352-1290
Email	kimura@takasaki-u.ac.jp

Public contact
Name of contact person	1st name Michiyo Middle name Last name Kimura
Organization	Takasaki University of Health and Welfare
Division name	Faculty of Health and Welfare
Zip code	3700033
Address	37-1 Nakaorui,Takasaki city,Gunma
TEL	0273521290
Homepage URL
Email	kimura@takasaki-u.ac.jp

Sponsor
Institute	Takasaki University of Health and Welfare Faculty of Health and Welfare
Institute
Department

Funding Source
Organization	Meiji Co.,Ltd R&D Division Food Development Laboratories
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Takasaki University of Health and Welfare
Address	37-1 Nakaorui,Takasaki city,Gunma
Tel	0273521290
Email	mune@takasaki-u.ac.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 09 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	33
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	2020 Year 02 Month 12 Day
Date of IRB	2020 Year 03 Month 06 Day
Anticipated trial start date	2020 Year 08 Month 28 Day
Last follow-up date	2021 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	2020 Year 09 Month 15 Day
Last modified on	2022 Year 02 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047727