UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000056884 |
|---|---|
| Receipt number | R000064791 |
| Scientific Title | Effects of Test Food Intake on Oxidative Stress and Antioxidant Capacity Study (Subtitles: Effects on Oxidative Stress and Antioxidants Capacity Pre- and Post-Exercise Load) |
| Date of disclosure of the study information | 2026/01/31 |
| Last modified on | 2025/09/04 13:31:41 |
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Basic information
Public title
Effects of Test Food Intake on Oxidative Stress and Antioxidant Capacity Study (Subtitles: Effects on Oxidative Stress and Antioxidants Capacity Pre- and Post-Exercise Load)
Acronym
Effects of Test Food Intake on Oxidative Stress and Antioxidant Capacity Study (Subtitles: Effects on Oxidative Stress and Antioxidants Capacity Pre- and Post-Exercise Load)
Scientific Title
Effects of Test Food Intake on Oxidative Stress and Antioxidant Capacity Study (Subtitles: Effects on Oxidative Stress and Antioxidants Capacity Pre- and Post-Exercise Load)
Scientific Title:Acronym
Effects of Test Food Intake on Oxidative Stress and Antioxidant Capacity Study (Subtitles: Effects on Oxidative Stress and Antioxidants Capacity Pre- and Post-Exercise Load)
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous intake of the test food for four weeks on oxidative stress and antioxidant capacity pre- and post-exercise load.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
d-ROMs
Key secondary outcomes
Biological Antioxidant Potential (BAP)
Urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG)
Oxidized Low-Density Lipoprotein (Oxidized LDL)
High-sensitivity C-reactive protein (hs-CRP)
Antioxidant-related markers
Salivary cortisol
Brief Profile of Mood States 2nd Edition (POMS2)
Visual Analog Scale (VAS) for fatigue
Brief-Type Self-Administered Diet History Questionnaire (BDHQ)
International Physical Activity Questionnaire (IPAQ) Short Form
Skin questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will replace one meal per day with the test food at lunch for four weeks.
Interventions/Control_2
Participants will consume their regular lunch without replacing it with the test food.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 20 to below 65 years at the time of consent acquisition.
2. Individuals who can consume the entire amount of the test food for lunch during the study period without any difficulty.
3. Individuals capable of performing the specified exercise routines implemented during the study.
4. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims of antioxidant or stress-reduction properties, three or more times a week.
2. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims of antioxidant or stress-reduction properties and are unable to discontinue use from the time of consent acquisition.
3. Individuals taking medication that may impact the study (like birth control pills) at least once a week and cannot limit their use during the study period.
4. Individuals with regular exercise habits or who perform physical labor.
5. Individuals planning to engage in activities during the study period that might affect the results, such as exercise, physical labor, outdoor activities, travel, or business trips:
- Intense or long-duration exercises.
- Outdoor activities that involve extensive sun exposure or prolonged outdoor exposure.
6. Individuals who may have difficulty participating in exercise due to surgical conditions or medical disorders
7. Individuals with oral symptoms involving bleeding, such as bleeding from the gums noticeable without brushing or any other stimulation, where the water used for rinsing turns visibly colored.
8. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
9. Individuals with extremely irregular lifestyles, such as those working night shifts.
10. Individuals with highly irregular eating habits.
11. Individuals who are aware of excessive salt intake in their regular diet.
12. Individuals with excessive alcohol intake.
13. Individuals who smoke or have a history of smoking within the last six months from the date of consent meeting.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nissin Foods Holdings 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
| 2025 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
14. Individuals who are expected to undergo significant changes in their living or working environment during the study period, such as moving or job transfers.
15. Individuals who plan to take medication for hay fever during the study period or have experienced hay fever symptoms during the study period in the past.
16. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
17. Individuals diagnosed with arrhythmia.
18. Females who are pregnant, breastfeeding, or intending to become pregnant during trial period.
19. Individuals with allergies to medications and/or food.
20. Individuals who donated 200 mL of their blood or blood components within the last month.
21. Individuals who donated 400 mL of his blood within the last 3 months.
22. Individuals who donated 400 mL of her blood within the last 4 months.
23. Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
24. Individuals who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
25. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2025 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064791
