UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055250 |
|---|---|
| Receipt number | R000062790 |
| Scientific Title | Study to Evaluate the Effects of Test Food Consumption on Improving Exercise Performance and Reducing Fatigue in Japanese Women |
| Date of disclosure of the study information | 2025/08/16 |
| Last modified on | 2024/10/21 13:52:10 |
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Basic information
Public title
Study to Evaluate the Effects of Test Food Consumption on Improving Exercise Performance and Reducing Fatigue in Japanese Women
Acronym
Study to Evaluate the Effects of Test Food Consumption on Improving Exercise Performance and Reducing Fatigue in Japanese Women
Scientific Title
Study to Evaluate the Effects of Test Food Consumption on Improving Exercise Performance and Reducing Fatigue in Japanese Women
Scientific Title:Acronym
Study to Evaluate the Effects of Test Food Consumption on Improving Exercise Performance and Reducing Fatigue in Japanese Women
Region
| Japan |
Condition
Condition
Female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of test food consumption on improving exercise performance and reducing post-exercise fatigue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise performance, Fatigue measured by VAS questionnaire (during exercise)
Key secondary outcomes
Rating of Perceived Exertion (RPE), Maximal Oxygen Uptake (VO2max), Physical Working Capacity at 75% of Maximum Heart Rate (PWC@75%HRmax), Heart Rate during exercise, Lactate Dehydrogenase (LD/IFCC), Creatine Kinase (CK), Creatinine, Lactate, Glucose (GLU), Cortisol, Catecholamines, Insulin, Interleukin-6 (IL-6), Growth Hormone, Glucagon, Free Fatty Acids, Estradiol, Progesterone, Blood Short-Chain Fatty Acids, Gut Microbiota, Fecal Short-Chain Fatty Acids, Fecal Bacterial Count, Muscle Mass, Body Fat Mass, Short Form-8 Health Survey (SF-8), Menstrual-related Questionnaire, Fatigue measured by VAS questionnaire (during daily activities)
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
Consumption of the test food (4 tablet a day) for 9 weeks
Interventions/Control_2
Consumption of the placebo food (4 tablet a day) for 9 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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1. Women aged 20 to below 50 years at the time of consent acquisition.
2. Subjects who engage in exercise habits once or twice a week (for at least 20 minutes per session).
*Exercise is defined as activities corresponding to 3.5 METs or more according to the revised "METs Table for Physical Activities" published by the National Institute of Health and Nutrition (NIHN), excluding resistance (weight) training.
3. Subjects who can maintain their exercise habits from before the study throughout the trial period.
4. Subjects who have not consumed prohibited foods or medications (listed in 'Other') within one week prior to obtaining consent and can refrain from consuming them during the trial period.
5. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Smokers (excluding those who have been non-smokers for more than one year).
2. Subjects who have bowel movements less than twice a week or have weak gastrointestinal health or are prone to diarrhea, as determined by background checks during the preliminary examination.
3. Subjects with excessive alcohol intake.
4. Subjects with extremely irregular eating habits or those with irregular life rhythms, such as shift workers or night shift workers.
5. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials.
6. Subjects who donated blood or component (200 mL) within the last 1 months.
7. Subjects who donated her blood (400 mL) within the last 4 months.
8. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this study.
9. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
10. Subjects with allergies to medications and/or food.
11. Subjects who are pregnant or lactating, and females who could become pregnant during trial period.
12. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
30
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 | Masanori |
| Middle name | |
| Last name | Numa |
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
Asahi Quality & Innovations, 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
| 2025 | Year | 08 | Month | 16 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 20 | 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 | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062790
