UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051522 |
|---|---|
| Receipt number | R000058768 |
| Scientific Title | Verification study on the effect of the test foods on physical fitness. |
| Date of disclosure of the study information | 2023/07/04 |
| Last modified on | 2024/10/21 13:40:18 |
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Basic information
Public title
Verification study on the effect of the test foods on physical fitness.
Acronym
Verification study on the effect of the test foods on physical fitness.
Scientific Title
Verification study on the effect of the test foods on physical fitness.
Scientific Title:Acronym
Verification study on the effect of the test foods on physical fitness.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this 12-weeks study is to verify the effect of the test foods on improvement physical fitness in Japanese healthy male/female adults, who are feeling their physical fitness declined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-min walk test
Key secondary outcomes
Grasping power
Sit-ups
Anteflexion
Repetitive side jump
Standing broad jump
Step workout
10-m walk test
Vertical jump
d-ROMs
BAP
Simple OSP (urinary 8-OHdG/creatinine corrected, PAO)
Oxidized LDL
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of test food for 12 weeks
Interventions/Control_2
Daily intake of placebo (control food) for 12 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Japanese healthy male/female who are 20 years of age or older at the time consent.
2.Those who are feeling their physical fitness declined.
3.Those who have an ADL score of 24 or higher and can take a physical fitness test.
4.Those who have signed a consent form prior to the start of the study upon full explanation of the purpose and content of the study.
Key exclusion criteria
1.Those who suffer from or have a history or present condition of liver disease, kidney disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension or other chronic diseases.
2.Those who are on treatment for a serious illness.
3.Those who have found ischemia or arrhythmia in a medical examination, etc., and have been pointed out.
4.Those who have a history of orthopedic surgery such as hips and knees that interfere with movement.
5.Those who have difficulty in exercising due to back pain, knee pain, etc.
6.Those who are prohibited from exercising by a physician.
7.Those with SBP greater than 160 mmHg or DBP greater than 100 mmHg at screening test.
8.Those with food allergies or those who may be allergic to the test food.
9.Those who regularly use licensed drugs or quasi-drugs that may affect the study.
10.Those who regularly use health foods that may affect the study.
11.Those who are participating in a clinical trial or have participated in another clinical trial within 1 months from the date of obtaining consent.
12.Those who are habitual smokers or who smoked within one year before the start of the study.
13.Those who have irregular daily life.
14.Those who may be unable to maintain their daily lifestyle.
15.Those who are pregnant or breastfeeding or planning to become pregnant during the study.
16.Those who plan to participate in any other clinical trial during the study.
17.Those who are being treated or have a history of malignant tumors, heart failure, or myocardial infarction.
18.Those who have implanted pacemakers or implantable cardioverter defibrillators.
19.Those who have a habit of regular exercise.
20.Those who may take unscheduled exercise or plan to start exercise by this December.
21.Those who are professional athletes.
22.Those who are undergoing treatment for chronic diseases.
23.Those who regularly drink exceeding 20 g of alcohol equivalent per day.
24.Those who are deemed inappropriate for this study by the investigator.
Target sample size
166
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Segawa |
Organization
Nissin York Co., Ltd
Division name
Development Laboratories
Zip code
3480005
Address
272, Tsutsumine, Kamimurakimi, Hanyu, Saitama, Japan
TEL
048-565-4686
shuichi.segawa@nissin.com
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
1040027
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo, Japan
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Ethics Review Committee of Watanabe Hospital
Address
1-5-6, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
r.k@kanamori.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
医療法人社団 渡辺病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 04 | 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
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 04 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058768
