UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049590 |
|---|---|
| Receipt number | R000056475 |
| Scientific Title | A Study to Evaluate Constant Load Exercise Performance After Ingestion of Test Food in Healthy Adult Men - A Randomized, Double-Blind, Placebo-Controlled Crossover Trial- |
| Date of disclosure of the study information | 2022/11/23 |
| Last modified on | 2022/11/22 22:07:16 |
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Basic information
Public title
A Study to Evaluate Constant Load Exercise Performance After Ingestion of Test Food in Healthy Adult Men
- A Randomized, Double-Blind, Placebo-Controlled Crossover Trial-
Acronym
A Study to Evaluate Constant Load Exercise Performance After Ingestion of Test Food
- A Randomized, Double-Blind, Placebo-Controlled Crossover Trial-
Scientific Title
A Study to Evaluate Constant Load Exercise Performance After Ingestion of Test Food in Healthy Adult Men
- A Randomized, Double-Blind, Placebo-Controlled Crossover Trial-
Scientific Title:Acronym
A Study to Evaluate Constant Load Exercise Performance After Ingestion of Test Food
- A Randomized, Double-Blind, Placebo-Controlled Crossover Trial-
Region
| Japan |
Condition
Condition
Healthy Male Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of a single dose of test food on the performance of constant-load exercise (three conditions with different exercise load conditions).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygen uptake
Key secondary outcomes
Oxygen utilization efficiency, ventilation rate, carbon dioxide expiration rate, respiratory exchange ratio, respiratory rate, heart rate, blood lactate concentration, blood active ingredient concentration, urinary active ingredient excretion, subjective exercise intensity
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
6
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Exercise load (25%VO2max) and placebo
blood drawing
Interventions/Control_2
Exercise load (25%VO2max) and test food (active ingredient 10mg)
blood drawing
Interventions/Control_3
Exercise load (50%VO2max) and placebo
blood drawing
Interventions/Control_4
Exercise load (50%VO2max) and test food (active ingredient 10mg)
blood drawing
Interventions/Control_5
Exercise load (75%VO2max) and placebo
blood drawing
Interventions/Control_6
Exercise load (75%VO2max) and test food (active ingredient 10mg)
blood drawing
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1)Healthy subjects who are aged 20-59
2)Subjects who can participate in dietary interventions, intake of test foods, blood samplings, urine samplings, and maintain rest as scheduled
3)Subjects who voluntarily give written informed consent
Key exclusion criteria
1)Subjects whose blood test results are judged to be ineligible for this study by lead principal investigator
2)Subjects with gastrointestinal, cardiovascular, endocrine, or other disorders, or with a history of such disorders, who are judged by lead principal investigator to be ineligible for the study
3)As a rule, subjects who regularly use drugs for the treatment of diseases
4)Subjects with allergies
5)Subjects who are judged to be ineligible for this study by lead principal investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Yoshinogari-cho, Kanzaki-gun, Saga
TEL
+81-952-52-1522
Ikeda.Yasutaka@otsuka.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Yoshinogari-cho, Kanzaki-gun, Saga
TEL
+81-952-52-1522
Homepage URL
Ikeda.Yasutaka@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
Tel
+81-3-6717-1499
shimizu_se@otsuka.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
| 2022 | Year | 11 | Month | 23 | Day |
Related information
URL releasing protocol
under submission
Publication of results
Unpublished
Result
URL related to results and publications
under submission
Number of participants that the trial has enrolled
25
Results
Test food significantly reduced VO2.
Results date posted
| 2022 | Year | 11 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy Volunteers
Participant flow
Subjects were selected based on the key inclusion and exclusion criteria.
Adverse events
ND
Outcome measures
Primary Outcomes:
Oxygen Uptake
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 10 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 22 | Day |
Last modified on
| 2022 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056475
