UMIN-CTR Clinical Trial

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
Email	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
Email	osuka@tmig.or.jp

Sponsor
Institute	Tokyo Metropolitan Institute of Gerontology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032688