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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041066
Receipt No. R000046902
Scientific Title Verification of the usefulness of food material intake for physical deterioration caused by aging -Randomized double-blind parallel group comparison method-
Date of disclosure of the study information 2020/07/13
Last modified on 2020/07/10

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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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 09 Day
Date of IRB
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
2020 Year 07 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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