UMIN-CTR Clinical Trial

Basic information
Public title	Trial of the effect of food ingredients and exercise on muscle function (SWE-2019-05-HBLOCO)
Acronym	Trial of the effect of food ingredients and exercise on muscle function
Scientific Title	Trial of the effect of food ingredients and exercise on muscle function (SWE-2019-05-HBLOCO)
Scientific Title:Acronym	Trial of the effect of food ingredients and exercise on muscle function
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of nutrition and exercise on muscle function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of changes in femoral muscle cross-sectional area during the 24th week intervention period
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	Supplementation of low-dose food ingredient and exercise
Interventions/Control_2	Supplementation of high-dose food ingredient and exercise
Interventions/Control_3	Supplementation of placebo and exercise
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	50 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Women and men aged 50 to 74 years at the time of acquisition of agreement in participating in this study 2) Person who does not engage regular exercise. 3) Person who can come to the medical organization for the measurement at the date of visiting 4) Person who can understand the purpose and content of this study and agree in writing to participate in this study
Key exclusion criteria	1) Presence of disease in locomotor organs affecting the efficacy assessment of this study. 2) Presence of health problems to perform exercise. 3) Use of supplement affecting the data of this study. 4) With previous and present serious disease such as cardiac affection, liver disorder, kidney disorder, cardiovascular disorder, lung disorder, diabetes mellitus. 5) Investigator's judgment for other reason.
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Izumo
Organization	Suntory Wellness Limited
Division name	Institute For Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL	050-3182-0630
Email	Takayuki_Izumo@suntory.co.jp

Public contact
Name of contact person	1st name Yuta Middle name Last name Otsuka
Organization	Suntory Wellness Limited
Division name	Institute For Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL	050-3182-0671
Homepage URL
Email	Yuta_Otsuka@suntory.co.jp

Sponsor
Institute	Suntory Wellness Limited
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuda Clinic
Address	1-6-1 Miyahara, Yodogawa-ku, Osaka
Tel	06-6398-0203
Email	fukudaclinicIRB@gmail.com

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 02 Month 28 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	Completed
Date of protocol fixation	2019 Year 08 Month 06 Day
Date of IRB	2019 Year 06 Month 15 Day
Anticipated trial start date	2019 Year 08 Month 10 Day
Last follow-up date	2020 Year 03 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 08 Day
Last modified on	2021 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042911