UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041066 |
|---|---|
| Receipt number | 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 | 2022/01/27 09:26:38 |
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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
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
ryo_uchida@ajinomoto.com
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046902
