UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041441 |
|---|---|
| Receipt number | R000047287 |
| Scientific Title | Validation study of effects of test food ingestion on subjective symptoms and performance after exercise. |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2021/07/20 18:34:46 |
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Basic information
Public title
Validation study of effects of test food ingestion on subjective symptoms and performance after exercise.
Acronym
Validation study of effects of test food ingestion on subjective symptoms and performance after exercise.
Scientific Title
Validation study of effects of test food ingestion on subjective symptoms and performance after exercise.
Scientific Title:Acronym
Validation study of effects of test food ingestion on subjective symptoms and performance after exercise.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm effects for subjective symptoms and performance after exercise by 4-week consumption of test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale (VAS) of muscle soreness
Key secondary outcomes
VAS of fatigue
Muscle strength
Range of motion
In the blood levels of Myoglobin, CPK, CRP, LDH, GH and Collagen
SF-8 Standard
Incidence of adverse events and of side effects
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Intake one package of test food dissolved in water (~100 ml) twice a day for 33 days - Wash out period [23 days] - Intake one package of control food dissolved in water (~100 ml) twice a day for 33 days
Interventions/Control_2
Intake one package of control food with water (~100 ml) twice a day for 33 days - Wash out period [23 days] - Intake one package of test food with water (~100 ml) twice a day for 33 days
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) Healthy Males aged over 40 to under 65 years when informed consent was given.
(2) Those who don't currently have a habit of exercise but did in the past.
(3) Those whose BMI ranges from 18.5 kg/m2 to 30 kg/m2.
(4) Those who receive enough explanation of the test, deeply understand it, and give written consent for the participation.
Key exclusion criteria
(1) Those who have previous and/or current medical history of serious disease.
(2) Those who habitually take medicines possibly affecting the test results or who can't restrict them.
(3) Those who have allergy to medicine and/or food (including allergy to collagen and gelatin).
(4) Those who habitually take the following products possibly affecting the test results or those who can not restrict them: Food for Specified Health Uses, Food with Function Claim, Food with Nutrient Function Claim, health foods, dietary supplement, sport nutrition products (e.g., BCAA, Protein, Protein Bar, Protein Drink), energy drinks (e.g., Red Bull), and nutritional drink (e.g., Lipovitan D).
(5) Those who have a taste for collagen-rich meals such as "motsu" and "horumon", and actively take them more than 4 times a week.
(6) Those who had exercises and/or activities with muscle pain during the last one month before SCR test.
(7) Those who plan to have exercises and/or activities with muscle pain during the test period.
(8) Those who habitually have body-care.
(9) Those who can't participate in the test on schedule.
(10) Those who have smoking habit.
(11) Those who take a lot of alcohol.
(12) Those who have extremely irregular life style.
(13) Those who are currently participating in other clinical trials of medicine or health food, or who did within 4-weeks, or who plan to do just after giving informed consent.
(14) Those who donated 200 mL of whole blood and/or blood components during the last one month before starting this clinical trial.
(15) Those who donated 400 mL of whole blood during the last three months before starting this clinical trial.
(16) Those whose total blood collection volume exceeds 1200 mL when the amount of blood collection in the clinical trial and it during the last 12 months before the starting are summed.
(17) Those who have been determined ineligible to participate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Fujiwara |
Organization
CPCC Company Limited
Division name
Division of Clinical Research
Zip code
101-0047
Address
4F Sanwa-uchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
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
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwa-uchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nippi, Incorporated
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 Sanwa-Uchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel
03-5297-5548
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
| 2021 | Year | 08 | Month | 20 | 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
| 2020 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 01 | 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
| 2020 | Year | 08 | Month | 17 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047287
