UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028560 |
|---|---|
| Receipt number | R000032688 |
| Scientific Title | Effects of strength exercise and beta-hydroxy-beta-methylbutyrate (HMB) on muscle mass and function |
| Date of disclosure of the study information | 2017/08/07 |
| Last modified on | 2021/10/13 14:46:13 |
* 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
Effects of strength exercise and beta-hydroxy-beta-methylbutyrate (HMB) on muscle mass and function
Acronym
Effects of strength exercise and beta-hydroxy-beta-methylbutyrate (HMB) on muscle mass and function
Scientific Title
Effects of strength exercise and beta-hydroxy-beta-methylbutyrate (HMB) on muscle mass and function
Scientific Title:Acronym
Effects of strength exercise and beta-hydroxy-beta-methylbutyrate (HMB) on muscle mass and function
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the combined effects of strength exercise and HMB supplement on skeletal muscle-related outcomes among older women with reduced muscle mass.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Muscle mass
Key secondary outcomes
Muscle strength, muscle quality, skin quality, sarcopenia scale, blood samples, performance test, habitual physical activity, dietary intake, diary, and health-related 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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Phase 1 (12 weeks): Strength exercise (2 days/week) and HMB (1200 mg/day).
Washout (12 weeks).
Phase 2 (12 weeks): Health education (1 day/2 week) and placebo (every day)
Interventions/Control_2
Phase 1 (12 weeks): Strength exercise (2 days/week) and placebo (every day)
Washout (12 weeks)
Phase 2 (12 weeks): Health education (1 day/2 weeks) and HMB (1200 mg/day)
Interventions/Control_3
Phase 1 (12 weeks): Health education (1 day/2 weeks) and HMB (1200 mg/day)
Washout (12 weeks)
Phase 2 (12 weeks): Strength exercise (2 days/week) and placebo (every day)
Interventions/Control_4
Phase 1 (12 weeks): Health education(1 day/2 weeks) and placebo (every day)
Washout (12 weeks)
Phase 2 (12 weeks): Strength exercise (2 days/week) and HMB (1200 mg/day)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Participants who
1) were older women aged 65 years and more.
2) had reduced muscle mass (SMI<5.7).
3) provided informed consent for screening.
Key exclusion criteria
Participants who
1) were restricted from exercising by a medical doctor.
2) were taking other supplements for muscle mass gain.
3) had impaired cardiac (e.g., with cardiac pacemaker implants), kidney, and liver functions.
4) were judged ineligible by a medical doctor.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Hunkyung |
| Middle name | |
| Last name | Kim |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence of the Elderly
Zip code
173-0015
Address
35-2, Sakae-cho, Itabshi-ku, Tokyo
TEL
03-3964-3241
kimhk@tmig.or.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Osuka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence of the Elderly
Zip code
173-0015
Address
35-2, Sakae-cho, Itabshi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
osuka@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
KYOWA Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute of Gerontology Institutional Review Board
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-3241
rinsyoushiken@tmghig.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
東京都健康長寿医療センター研究所（東京都）/Tokyo Metropolitan Institute of Gerontology (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/9/2/e025723.long
Publication of results
Partially published
Result
URL related to results and publications
https://academic.oup.com/ajcn/article-abstract/114/4/1371/6291734?redirectedFrom=fulltext
Number of participants that the trial has enrolled
156
Results
HMB additively increased gait speed with small benefits and provided no enhancements in the effects of exercise on other outcomes. Exercise appeared to be the only effective program to improve outcomes in older women with low muscle mass.
Results date posted
| 2021 | Year | 10 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Older women with low muscle mass
Participant flow
1. Eligibility assessment
2. Baseline survey
3. Intervention
4. Post-intervention survey
5. Observation
6. Follow-up survey
Adverse events
Exercise-related adverse events were not observed.
Eight adverse events, potentially related to HMB supplementation, were reported (nausea: n = 1, stomach discomfort: n = 2, whole-body discomfort: n = 1, increased urinary frequency: n = 2, pruritus: n = 1, and high blood pressure: n = 1).
No significant differences in the number of participants who reported these adverse events between the HMB and placebo groups.
Outcome measures
1. Muscle mass
2. Muscle strength
3. Physical performance
4. Blood test
5. Functional capacity
6. Physical activity/Diet history
7. Muscle quality
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 07 | Day |
Last modified on
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032688
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
