UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046144
Receipt No. R000052666
Scientific Title The effect of milk fat globule membrane ingestion combined with exercise on physical function
Date of disclosure of the study information 2021/11/23
Last modified on 2021/11/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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
2021 Year 11 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.