UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060855 |
|---|---|
| Receipt number | R000069557 |
| Scientific Title | Effects of test food consumption and Exercise load on muscle. -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/06 16:52:02 |
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Basic information
Public title
Effects of test food consumption and Exercise load on muscle.
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
Effects of test food consumption and Exercise load on muscle.
Scientific Title
Effects of test food consumption and Exercise load on muscle.
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
Effects of test food consumption and Exercise load on muscle.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of test food consumption and exercise load on muscle.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass after 12 weeks of intake
Key secondary outcomes
Muscle strength after 12 weeks of intake
VAS questionnaire results after 12 weeks of intake
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
12-week consumption of the test food
Exercise at the gym and home
Interventions/Control_2
12-week consumption of the placebo food
Exercise at the gym and home
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese males and females aged 40 to 74 years-old.
2) Subjects who do not exercise regularly and are aware of declines in muscle strength than before.
3) Subjects whose BMI are under 30.
4) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects(who)
1) regularly use drugs associated with muscle, lipid metabolism and/or amino acids preparations.
2) contract or have a history of serious diseases (eg, liver, kidney, digestive, heart, respiratory, endocrine, metabolic, skeletal muscle and/or tendon disease)
3) are undergoing or may receive surgical treatment of knee joints.
4) with a cardiac pacemaker or artificial joint, etc.
5) have had severe damage on the locomotive organs such as fracture, tendon rupture, or muscle strain in the past 1 year.
6) with physical disabilities such as severe low back pain and knee pain, which interfere with exercise.
7) are suspected to have sarcopenia as a result of screening.
8) contract or have a surgical history of digestive disease affecting digestion and absorption.
9) can't stop using supplements, and/or functional foods (including Food for Specified Health Uses, Foods with Function Claims or nutritional supplements which contain amino acids and/or proteins).
10) are prohibited from exercising by doctors.
11) declared allergic reactions to foods.
12) can't stop drinking from 2 days before each measurement.
13) have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week.
14)are shift worker and/or midnight-shift worker.
15) are under treatment for or have a history of drug addiction and/or alcoholism.
16) are judged unsuitable as a subject by the investigator based on clinical testing during screening.
17) have donated over 200 mL of blood and/or blood components within the last one month prior to the consent or over 400 mL of blood and/or blood components within the last three months prior to the consent.
18) are pregnant or planning to become pregnant or breastfeed during the study period.
19) are participating in or willing to participate in other clinical studies.
20) are judged unsuitable as a subject by the investigator for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuge |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Toyo Shinyaku Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.co.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 06 | 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
| 2026 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069557
