UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047563 |
|---|---|
| Receipt number | R000054240 |
| Scientific Title | Exploratory study to examine continued effects of test food on oxygen utilization during exercise in healthy adult males. A randomized, double-blind, placebo-controlled, crossover study. |
| Date of disclosure of the study information | 2022/04/28 |
| Last modified on | 2022/10/21 09:10:13 |
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Basic information
Public title
Exploratory study to examine continued effects of test food on oxygen utilization during exercise in healthy adult males.
A randomized, double-blind, placebo-controlled, crossover study.
Acronym
Exploratory study to examine continued effects of test food on oxygen utilization during exercise in healthy adult males.
A randomized, double-blind, placebo-controlled, crossover study.
Scientific Title
Exploratory study to examine continued effects of test food on oxygen utilization during exercise in healthy adult males.
A randomized, double-blind, placebo-controlled, crossover study.
Scientific Title:Acronym
Exploratory study to examine continued effects of test food on oxygen utilization during exercise in healthy adult males.
A randomized, double-blind, placebo-controlled, crossover study.
Region
| Japan |
Condition
Condition
Healty subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore continued effects on oxygen utilization during exercise in healthy adult males after a single intake of placebo or test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygen uptake
Key secondary outcomes
Ventilatory equivalent for oxygen, Ventilatory equivalent, Carbon dioxide output, Ventilatory equivalent for carbon dioxide, Respiratory exchange ratio, Respiratory rate
Heart rate, Heart rate variability
Subjective exercise intensity (RPE)
Blood lactate concentration
Urinary excretion
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single intake of test food
Interventions/Control_2
Single intake of placebo 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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1) Healthy adult males
2) Persons who are able to intake foods, beverage, placebo/test foods, collect urine and stay at rest according to the predetermined schedule
Key exclusion criteria
1) Persons whose clinical laboratory test values are judged to be ineligible for the study by the investigator.
2) Persons with or have a history of disorders of the digestive, circulatory, endocrine system, and are judged to be eligible for the study by the investigator.
3) Persons who habitually use drugs for the purpose of treating diseases, in principal.
4) Persons who use healthy food or supplement which are able to affect this study.
5) Persons with food allergies.
6) Persons who are judged to be ineligible for the study for any other reason by the investigator.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Tsubasa |
| Middle name | |
| Last name | Mizokami |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Yoshinogari-cho Kanzaki-gun, Saga,
TEL
0952-52-1522
Mizokami.Tsubasa@otsuka.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Mizokami |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Yoshinogari-cho Kanzaki-gun, Saga,
TEL
0952-52-1522
Homepage URL
Mizokami.Tsubasa@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
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
Tel
03-6717-1499
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 | 04 | Month | 28 | 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
15
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
| 2022 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 24 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 26 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 27 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 22 | Day |
Last modified on
| 2022 | 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=R000054240
