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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030897
Receipt No. R000035279
Scientific Title Muscle strength and body function confirmation test by functional material supplementation-double-blind parallel group comparison test (RCT test) - "double-blind parallel group comparison test
Date of disclosure of the study information 2019/05/30
Last modified on 2018/01/19

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Basic information
Public title Muscle strength and body function confirmation test by functional material supplementation-double-blind parallel group comparison test (RCT test) - "double-blind parallel group comparison test
Acronym Muscle strength and body function confirmation test by functional material supplementation (RCT test)
Scientific Title Muscle strength and body function confirmation test by functional material supplementation-double-blind parallel group comparison test (RCT test) - "double-blind parallel group comparison test
Scientific Title:Acronym Muscle strength and body function confirmation test by functional material supplementation (RCT test)
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove clinical benefits associated with daily HMB-Ca supplementation for 12 weeks on body fat reduction and effect of physical function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Body weight, BMI, body fat percentage, muscle mass, body fat mass, limb muscle mass, waist size
Key secondary outcomes Grip strength, One-leg standing duration with vision, One-leg standing duration with no vision, 10 m walking speed,
Lower limb extensor strength, questionnaire

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 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of HMBCa for 1.5g/day and 12 weeks
Interventions/Control_2 Intake of HMBCa for 2.0g/day and 12 weeks
Interventions/Control_3 Intake of placebo 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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria [1] Males and females aged 20-60 years
[2] Subjects equal to or more than 22 and less than 30 kg/m^2 of BMI and do not fall under the diagnostic criteria of metabolic syndrome
[3] Subjects whose fat mass is over 20
[4] Subjects who are healthy and are currently not treating any serious disease
[5] Subjects who can visit facilities designated at the scheduled arrival date
[6] Subjects who agreed in writing after fully understanding the purpose and contents of this exam
Key exclusion criteria [1] Subjects who routinely use amino acids or protein-reinforced foods or drinks for maintaining physical strength, improving exercise function or dieting
[2] Subjects who have periodic exercise habits more than twice a week
[3] Subjects who are difficult to participate in the examination due to liver, kidney, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, disturbance of consciousness, diabetes (according to the standards set by the Japan Diabetes Association)
[4] Subjects who has a history of cardiovascular disease
[5] Subjects who regularly use medicines that may affect this examination, health foods / supplements (including foods for specified health use, functional display foods and nutrient function foods) (However, ingestion can be stopped at the time of consent acquisition The person does not apply)
[6] Subjects who are allergic to the test food
[7] Subjects who has experienced mood disorder or condition deterioration due to blood collection in the past
[8] Subjects who donated blood of 200 mL or more from the beginning of the test until the start of the test or those who have the schedule during the test period
[9] Participating in other clinical trials or within 4 weeks after the examination
[10] Alcohol drinkers and excessive smokers
[11] Subjects whose diet is extremely irregular
[12] Subjects who can not agree with the purpose of this test conducted in advance
[13] Others who are deemed inappropriate for participation in this study by a doctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Akanuma
Organization Akanuma Surgery Clinic
Division name Department
Zip code
Address 14-1, Isiyama2-jo 6, , Minami-ku Sapporo-shi, Hokkaido
TEL 011-591-1777
Email kouzai@hmc.moo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kousuke Kurose
Organization Nakahara Co., Ltd
Division name R & D division
Zip code
Address 3-12-16 Shirahata, Minami-ku, Satitama-city, Saitama
TEL 048-710-8877
Homepage URL
Email kousuke.kurose@nakahara2001.co.jp

Sponsor
Institute Akanuma Surgery Clinic
Institute
Department

Funding Source
Organization Nakahara 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
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 赤沼外科医院(北海道)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 30 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
2017 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 30 Day
Last follow-up date
2018 Year 05 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 19 Day
Last modified on
2018 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035279

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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