UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054445 |
|---|---|
| Receipt number | R000062185 |
| Scientific Title | A study evaluating the physiological effect of repeated intake of food ingredient. |
| Date of disclosure of the study information | 2024/05/24 |
| Last modified on | 2025/12/03 09:48:20 |
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Basic information
Public title
A study evaluating the physiological effect of repeated intake of food ingredient.
Acronym
A study evaluating the physiological effect of repeated intake of food ingredient.
Scientific Title
A study evaluating the physiological effect of repeated intake of food ingredient.
Scientific Title:Acronym
A study evaluating the physiological effect of repeated intake of food ingredient.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the physiological effect and clinical safety of food ingredient after repeated intake for 4 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxidative stress-related parameters(urinary 8-OHdG, d-ROMs test, BAP test, OSI)
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects take test food 1 (containing food ingredient) for 4 weeks. Before and after repeated intake, subjects take blood/feces sampling and answer the survey.
Interventions/Control_2
Subjects take test food 2 (containing food ingredient) for 4 weeks. Before and after repeated intake, subjects take blood/feces sampling and answer the survey.
Interventions/Control_3
Subjects take control food for 4 weeks. Before and after repeated intake, subjects take blood/feces sampling and answer the survey.
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 and Female
Key inclusion criteria
(1) Healthy male and female subjects whose ages are 40<= years old <65.
(2) Subjects whose oxidative stress parameters (urinary 8-OHdG or OSI) are high.
(3) Subjects who can visit the clinic on the scheduled inspection days.
(4) Subjects who agree with the purpose and description of the study, and express informed consent via written documents.
(5) Subjects who can wear the device during the study period.
Key exclusion criteria
(1) Subjects judged necessary to receive treatment by the principal investigator.
(2) Subjects with any of the below:
a) with disease on heart, liver, kidney or other organs complications.
b) with respiratory disease
c) with a previous history of disease on circulatory organs.
d) contracting diabetes.
e) with allergy to test food components.
(3) With a previous history of severe disease such as inflammatory bowel disease or cancer or tuberculosis.
(4) Constantly taking prescription/non-prescription or herbal drug medicine.
(5) With allergic reaction to drug medicine and food.
(6) With a previous history of feeling sick after blood sampling.
(7) With difficulty in blood sampling from peripheral vein.
(8) Whose BMI is less than 18.5 or equal to or more than 30.0 kg/m2.
(9) With systolic pressure under 90 mmHg.
(10) Pregnant or lactating.
(11) Subjects donated over 200 ml blood components or whole blood within the past 4 weeks prior to the current study.
(12) Male who donated over 400 ml whole blood within the past 12 weeks prior to the current study.
(13) Female who donated over 400ml whole blood within the past 16 weeks prior to the current study.
(14) Male whose blood was collected over 1200 ml within the last 12 months.
(15) Female whose blood was collected over 800 ml within the last 12 months.
(16) Drinking alcohol a lot.
(17) With irregular eating patterns.
(18) Working irregular shifts or at midnight.
(19) With excessive exercise habits defined as 7METs; habits: 5 times a week, over 30 minutes per time.
(20) Smoking more than or equal to 21 cigarettes.
(21) Planning irregular lifestyle and events during the study.
(22) Participating in other clinical studies or finished study within the last 4 weeks.
(23) Subjects judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Ito |
Organization
SUN THERA BIO Ltd.
Division name
Research and Development
Zip code
213-0012
Address
East Tower 205, KSP Innovation Center, 3-2-1 Sakado Takatsu-ku, Kawasaki City, Kanagawa Pref. Japan
TEL
044-281-9701
mitoh@suntherabio.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Fukizawa |
Organization
SUN THERA BIO Ltd.
Division name
Research and Development
Zip code
213-0012
Address
East Tower 205, KSP Innovation Center, 3-2-1 Sakado Takatsu-ku, Kawasaki City, Kanagawa Pref. Japan
TEL
050-3182-0595
Homepage URL
Shinya_Fukizawa@suntory.co.jp
Sponsor or person
Institute
SUN THERA BIO Ltd.
Institute
Department
Personal name
Masashi Ito
Funding Source
Organization
Suntory Wellness Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building, 2-7-5 Higashiueno Taito-ku, Tokyo
Tel
03-6240-1162
info@ueno-asagao.clinic
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 | 05 | Month | 24 | 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
| 2024 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 19 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 19 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062185
