UMIN-CTR Clinical Trial

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
Email	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
Email	Mizokami.Tsubasa@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054240