UMIN-CTR Clinical Trial

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
Email	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
Email	Ikeda.Yasutaka@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
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 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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056475