UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054464 |
|---|---|
| Receipt number | R000062209 |
| Scientific Title | Effect of food-containing ingredients for motor function. SIC-2024-02-GUTS |
| Date of disclosure of the study information | 2024/06/06 |
| Last modified on | 2024/05/23 14:20:45 |
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Basic information
Public title
Effect of food-containing ingredients for motor function. SIC-2024-02-GUTS
Acronym
Effect of food-containing ingredients for motor function
Scientific Title
Effect of food-containing ingredients for motor function. SIC-2024-02-GUTS
Scientific Title:Acronym
Effect of food-containing ingredients for motor function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of food-containing ingredients for motor function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Index of motor function
Key secondary outcomes
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
Ingredient-containing food. 8 weeks
Interventions/Control_2
Ingredient-free food. 8 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
(1)Subjects who can make self-judgment and are voluntarily giving written informed consent.
(2)From 40 to 64 years healthy men and women.
(3)Subjects who can visit the facility on designated day.
Key exclusion criteria
1, Subjects whose systolic blood pressure is less than 90mmHg
2, Subjects in pregnancy or lactation
3, Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks
4, Subjects who are applicable to following items;
a, Subjects with disease on heart, liver, kidney or other organs complication.
b, Subjects with a previous history of disease on circulatory organs.
c, Subjects who are contracting diabetes.
d, Subjects with respiratory disease.
5, Subjects who have an unsteady lifestyle because of a working shift or a night shift.
6, Subjects who drink a lot.
7, Smoker except for subjects who quit smoking for more than a year.
8, Subjects whose BMI is less the 18.5 or over 25.
9, Subjects whose systolic pressure >160 mmHg or diastolic pressure >100 mmHg.
10, Subjects who are judged as unsuitable for the study by the result of clinical examination and/or physical examination.
11, Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Suzuki |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0596
Toshihide_Suzuki@suntory.co.jp
Public contact
Name of contact person
| 1st name | Keigo |
| Middle name | |
| Last name | Horiuchi |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0573
Homepage URL
Keigo_Horiuchi@suntory.co.jp
Sponsor or person
Institute
the other
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
IRB of of Fukuda Internal Medicine Clinic, a medical corpoIation
Address
2nd floor, Shin-Osaka Brick Building, 6-1 Miyahara 1-chome, Yodogawa-ku, Osaka City
Tel
06-6398-0203
fukudaclinicIRB@gmail.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
| 2024 | Year | 06 | 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
| 2024 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | 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 | 05 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062209
