UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038020 |
|---|---|
| Receipt number | R000043324 |
| Scientific Title | Verification of effects of test food intake |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2020/12/22 13:18:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of effects of test food intake
Acronym
Verification of effects of test food intake
Scientific Title
Verification of effects of test food intake
Scientific Title:Acronym
Verification of effects of test food intake
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of test food for physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Motor function, daily activity, body composition, questionnaire evaluation
Key secondary outcomes
Oxidative stress index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food for 12 weeks
Interventions/Control_2
Ingestion of placebo 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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese individuals aged 50-79 years.
2) Individuals who are healthy and are not suffered from a chronic malady.
3) Individuals whose ADL questionnaire scores is higher than 12.
4) Non-smoker
5) Individuals whose BMI scores is not less than 22.5 kg/m2 and less than 30.0 kg/m2.
6) Individulals who can visit an inspection facility and be inspected in designated days.
7) Individuals whose written informed consent has been obtained.
Key exclusion criteria
1) Those who meet the criteria of sarcopenia from the results of grip strength and gait speed (Male subjects whose grip strength values are less than 26.0kg and gait speed is less than 0.8 m/s. Female subjects whose grip strength values are less than 18.0kg and gait speed is less than 0.8m/s.)
2) Individuals who have been hospitalized with joint pains such as knees and lower back within 3 months
3) Individuals who is allergic to test food
4) Individuals with a large history of surgery on the gastrointestinal tract, such as gastrectomy, gastrointestinal suture, and intestinal resection
5) Individuals who have difficulty in participating in the study due to liver disease, kidney disease, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes, and other diseases
6) Individuals with a history of serious cardiovascular disease
7) Individuals who regularly use amino acid, protein-reinforced foods or beverages for the purpose of maintaining physical fitness, improving motor function or dieting
8) Individuals who regularly use medicines and supplements that may affect this study (However, those who can suspend intake at the time of the test are not applicable)
9) Individuals who have experienced bad mood or poor physical condition due to blood sampling in the past
10) Individuals who donated blood more than 200mL between the month before the start of the test, or who is scheduled to do so during the test period
11) Individuals who participated in other clinical studies in the past 4 weeks.
12) Individuals who drink a lot of alcohol
13) Individuals who have extremely irregular eating habits
14) Irregular shift workers
15) Individuals who do not agree with the purpose of the explanation of this examination
16) Individuals judged inappropriate for the study by the principal.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Akanuma |
Organization
Akanuma Surgery Clinic
Division name
Department
Zip code
005-0842
Address
14-1, Isiyama2-jo 6, Minami-ku Sapporo-shi, Hokkaido
TEL
011-200-9431
y-kohzai@kyowa-t.com
Public contact
Name of contact person
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Kozai |
Organization
Kyowa Trial Co., Ltd.
Division name
Clinical Trials Division
Zip code
064-0923
Address
1-40, minami 23-jo nisi 11-tyoume, tyuuou-ku Sapporo-shi, Hokkaido
TEL
011-200-9431
Homepage URL
https://www.kyowa-t.com/
y-kohzai@kyowa-t.com
Sponsor or person
Institute
Akanuma Surgery Clinic
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Akanuma surgery clinic ethics review board
Address
14-1, Isiyama2-jo 6, Minami-ku Sapporo-shi, Hokkaido
Tel
011-200-9431
y-kohzai@kyowa-t.com
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
| 2020 | Year | 03 | Month | 31 | 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
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 17 | Day |
Last modified on
| 2020 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043324
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
