UMIN-CTR Clinical Trial

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
Email	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
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047287