UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054813 |
|---|---|
| Receipt number | R000062619 |
| Scientific Title | Effect of test food consumption and Exercise on Physical Fitness -A Randomized, Single-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2024/06/28 |
| Last modified on | 2024/06/28 11:48:23 |
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Basic information
Public title
Effect of test food consumption and Exercise on Physical Fitness
-A Randomized, Single-blind, Placebo-controlled, Parallel-group Study-
Acronym
Effect of test food consumption and Exercise on Physical Fitness
Scientific Title
Effect of test food consumption and Exercise on Physical Fitness
-A Randomized, Single-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
Effect of test food consumption and Exercise on Physical Fitness
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of test food consumption on physical fitness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass
Key secondary outcomes
Muscle strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test foods, 12 weeks consumption
Exercise at gym and home
Interventions/Control_2
Control foods 1, 12 weeks consumption
Exercise at gym and home
Interventions/Control_3
Control foods 2, 12 weeks consumption
Exercise at gym and home
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy Japanese Males aged 20 to 40 years-old.
2) Subjects whose BMI are under 30.
3) 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 and/or lipid metabolism
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 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)contract or have a surgical history of digestive disease affecting digestion and absorption
8)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)
9)whose exercise is prohibited by doctors
10)declared allergic reactions to foods
11) can't stop drinking from 2 days before each measurement
12) 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
13)are shiftworker and/or midnight-shift worker
14)with a history of and/or current drug addiction and/or alcoholism
15)were judged as unsuitable for the current study by screening tests
16) have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study
17)are participating in or willing to participate in other clinical studies
18)were judged as unsuitable for the current study by the investigator for other reasons
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Sekiguchi |
Organization
Urayasu Sekiguchi Clinic
Division name
Director
Zip code
279-0004
Address
5-17-27 Nekozane, Urayasu-shi, Chiba
TEL
047-306-3557
scfira@royal.ocn.ne.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
| 2024 | Year | 06 | Month | 28 | 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
| 2024 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062619
