UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the usefulness of food material intake for physical deterioration caused by aging
Acronym	Verification of the usefulness of food material intake for physical deterioration caused by aging
Scientific Title	Verification of the usefulness of food material intake for physical deterioration caused by aging -Randomized double-blind parallel group comparison method-
Scientific Title:Acronym	Verification of the usefulness of food material intake for physical deterioration caused by aging -Randomized double-blind parallel group comparison method-
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study verifies efficacy in improving physical fitness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	muscle function
Key secondary outcomes	Physical fitness indices, Muscle indices, Questionnaire about QOL and feelings

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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	(1)Take test food once a day for 12 weeks (2) Participate in four exercise classes (3) Perform resistance exercise at home for 5 days a week
Interventions/Control_2	(1) Take placebo once a day for 12 weeks (2) Participate in four exercise classes (3) Perform resistance exercise at home for 5 days a week
Interventions/Control_3
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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Men and women between the ages of 50 and 69 with reduced muscle quality (2) 5 days a week during the test period, who can perform resistance exercise by own weight for 10 to 15 minutes at home (3) Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to consent, have well understood, volunteered to participate, and have signed the informed consent document
Key exclusion criteria	(1) Subjects who meet the sarcopenia criteria (2) Subjects who take more protein than necessary (3) Subjects whose physical activity level is too high (4) Subjects who regularly use medicines that may affect muscle and lipid metabolism and amino acid preparations (5) Subjects who cannot stop taking supplements and health foods (including foods for specified health uses and foods with functional claims) (6) Screening test, subjects unable to quit drinking 2 days before each test (7) Subjects with a history of drug dependence or alcohol dependence or current medical history (8) Subjects who participated in tests that use other foods and pharmaceuticals, tests that apply cosmetics and pharmaceuticals, etc. within 1 month from the time of obtaining consent, and subjects who participate in other tests while participating in this study (9) Subjects with systolic blood pressure of 160 mmHg or more at screening test or diastolic blood pressure of 100 mmHg or more (10) Subjects suffering from serious kidney disease, digestive system disease, heart disease, respiratory system disease, endocrine disease or other metabolic diseases, or subjects under treatment (11) Subjects with physical disabilities such as severe low back pain and knee pain, which interfere with exercise (12) Subjects with a history of orthopedic surgery that interferes with movements such as the waist and knees (13) Subjects with metal implants such as pacemakers and bolts (14) Subjects with difficulty measuring muscle mass and muscle quality (15) Subjects whose exercise is prohibited by doctors (16) Subjects who are judged as unsuitable for the study by the investigators
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Mine
Organization	Ajinomoto Co., Inc.
Division name	Human Health & Nutrition Group, Institute of Food Sciences and Technologies
Zip code	210-8681
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-223-4114
Email	tomoyuki_mine@ajinomoto.com

Public contact
Name of contact person	1st name Ryo Middle name Last name Uchida
Organization	Ajinomoto Co., Inc.
Division name	Human Health & Nutrition Group, Institute of Food Sciences and Technologies
Zip code	210-8681
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL	044-223-4114
Homepage URL
Email	ryo_uchida@ajinomoto.com

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical Committee of Nihonbashi Cardiology Clinic
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.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	医療法人財団健康睡眠会　日本橋循環器科クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 13 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	2020 Year 07 Month 09 Day
Date of IRB	2020 Year 07 Month 09 Day
Anticipated trial start date	2020 Year 08 Month 21 Day
Last follow-up date	2020 Year 12 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	2020 Year 07 Month 10 Day
Last modified on	2022 Year 01 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046902