UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056982 |
|---|---|
| Receipt number | R000065116 |
| Scientific Title | The effect of combining coffee beverages and lactic acid bacteria preparations on the antioxidant capacity of the body |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/02/08 18:39:34 |
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Basic information
Public title
The effect of combining coffee beverages and lactic acid bacteria preparations on the antioxidant capacity of the body
Acronym
The effect of combining coffee beverages and lactic acid bacteria preparations on the antioxidant capacity of the body
Scientific Title
The effect of combining coffee beverages and lactic acid bacteria preparations on the antioxidant capacity of the body
Scientific Title:Acronym
The effect of combining coffee beverages and lactic acid bacteria preparations on the antioxidant capacity of the body
Region
| Japan |
Condition
Condition
Normal person
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In addition to the antioxidant effects of coffee, the aim of this study is to verify the effects of using a lactic acid bacteria preparation in combination with coffee, and to examine the effects of each of these alone and the synergistic effects of the two together, using an intervention study on humans as an indicator of the antioxidant capacity of the body.
Basic objectives2
Others
Basic objectives -Others
Other
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The subjects will be asked to consume a can of coffee (per day) and a packet of lactic acid bacteria (per day) for two weeks, and blood samples will be taken before and after the consumption period to measure the serum activity of oxygen and free radical scavenging activity (hydroxyl radical, superoxide radical, alkyl hydroxy radical, alkyl peroxide radical, methyl radical, singlet oxygen).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Coffee beverage alone
Interventions/Control_2
Lactic acid bacteria preparation alone
Interventions/Control_3
Use both
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy person
Key exclusion criteria
Allergic constitution
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ichikawa |
Organization
Doshisha University
Division name
Department of Medical Life Systems, Faculty of Life and Medical Sciences
Zip code
610-0394
Address
1-3 Tataramiyakodani, Kyotanabe City
TEL
0774-65-6396
hichiikaw@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ichikawa |
Organization
Doshisha University
Division name
Major of Medical Life Systems, Graduate School of Life and Medical Sciences
Zip code
610-0394
Address
1-3 Tatara-Miyakodani, Kyotanabe City, Kyoto, Japan
TEL
0774-65-6396
Homepage URL
hichik@mti.biglobe.ne.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Doshisha University
Address
1-3, Tataramiyakodani, Kytanabe City
Tel
0774656396
hichikaw@mail.doshisha.ac.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
| 2025 | Year | 04 | Month | 01 | 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
24
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 | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2025 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065116
