UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Masanori Akanuma
Organization	Akanuma Surgery Clinic
Division name	Department
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	Kousuke Kurose
Organization	Nakahara Co., Ltd
Division name	R & D division
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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