UMIN-CTR Clinical Trial

Basic information
Public title	The effect of milk-derived components ingestion combined with exercise on physical function
Acronym	The effect of milk-derived components ingestion combined with exercise on physical function
Scientific Title	The effect of milk fat globule membrane ingestion combined with exercise on physical function
Scientific Title:Acronym	The effect of milk fat globule membrane ingestion combined with exercise on physical function
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of milk fat globule membrane ingestion combined with exercise on physical function for 4 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Muscle power of isokinetic knee extension exercise
Key secondary outcomes	Body composition Physical functions (maximum muscle strength, muscle power, agility, balance) Electromyography Rated perceived exertion

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
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	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Light exercise (3 times per week) Powder containing milk fat globule membrane, one pouch per day 4 weeks
Interventions/Control_2	Light exercise (3 times per week) Placebo, one pouch per day 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	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	1) Give a written informed consent 2) Males or females aged 20 to 39 years old 3) Able to perform 12 resistance training sessions (3 per week) in a 4 week period at a designated fitness club 4) Right-handed
Key exclusion criteria	1) Have previous/current medical history of serious disease with medication BMI>=30 Use implantable electronic medical devices 2) Contract an infectious disease 3) Contract a disease that cause temporary muscle spasms or loss of consciousness 4) Use drugs that may affect the results of the study 5) Have motor dysfunction Restricted exercise, intense movement, or bathing by the doctor 6) Have milk or soy allergies 7) Intake a lot of milk or daily products 8) Intake at least 5 g of whey protein per week 9) Smoker 10) Heavy drinker 11) Involved in regular vigorous exercise 12) Member of antisocial forces 13) Have received a notice of expulsion from employer or fitness club 14) Pregnant, breastfeeding or may become pregnant 15) Have participated in other clinical studies in the last month, or plan to participate during this study period 16) Judged as unsuitable for the study by the principal investigator for other reason
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Chiaki Middle name Last name Sanbongi
Organization	Meiji Co., Ltd.
Division name	R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL	+81-42-632-5846
Email	chiaki.sanbongi@meiji.co.jp

Public contact
Name of contact person	1st name Kyoko Middle name Last name Ito
Organization	Meiji Co., Ltd.
Division name	R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL	+81-42-632-5846
Homepage URL
Email	kyouko.itou@meiji.com

Sponsor
Institute	Meiji Co., Ltd.
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo, Japan
Tel	+81-3-5297-5548
Email	IRB@cpcc.co.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	2021 Year 11 Month 23 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	20
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	2021 Year 11 Month 19 Day
Date of IRB	2021 Year 11 Month 19 Day
Anticipated trial start date	2021 Year 11 Month 23 Day
Last follow-up date	2022 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 22 Day
Last modified on	2022 Year 09 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052666