UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030897 |
|---|---|
| Receipt number | 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 17:48:06 |
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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
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
kousuke.kurose@nakahara2001.co.jp
Sponsor or person
Institute
Akanuma Surgery Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035279
