UMIN-CTR Clinical Trial

Basic information
Public title	Trial of the efficacy of continuous intake of food ingredients on energy production.(SME-2020-03-HRCT)
Acronym	Trial of the efficacy of continuous intake of food ingredients on energy production.
Scientific Title	Trial of the efficacy of continuous intake of food ingredients on energy production.(SME-2020-03-HRCT)
Scientific Title:Acronym	Trial of the efficacy of continuous intake of food ingredients on energy production.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of food ingredients on energy production.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Oxygen consumption
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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 of the test foods and training (6 weeks)
Interventions/Control_2	Intake of the control foods and training (6 weeks)
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	39 years-old >=
Gender	Male
Key inclusion criteria	1)Men aged 20 to 39 years. 2)Person who can come to the medical and inspection organizations for the measurement at the date of visiting. 3)Person who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria	1)Person who has difficulty in implementation of exercise tolerance test. 2)Person whose gets high-intensity exercise on a daily basis. 3)Use of product affecting the data of this study, such as food for specified health use, food with function claims, and medicine. 4)Presence of previous and present disease such as chronic fatigue syndrome, sleep apnea syndrome, menopause, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy. 5)Investigator's judgment for other reason.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Hidenori Middle name Last name Obata
Organization	SUNTORY MONOZUKURI EXPERT LIMITED
Division name	HE Center
Zip code	135-8631
Address	2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL	03-5579-1277
Email	Hidenori_Obata@suntory.co.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Kitamura
Organization	SUNTORY MONOZUKURI EXPERT LIMITED
Division name	HE Center
Zip code	135-8631
Address	2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL	03-5579-1277
Homepage URL
Email	Ryo_Kitamura@suntory.co.jp

Sponsor
Institute	SUNTORY MONOZUKURI EXPERT LIMITED
Institute
Department

Funding Source
Organization	Suntory Wellness Limited
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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	080-2290-2544
Email	makabe295@eps.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 03 Month 17 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	2021 Year 03 Month 12 Day
Date of IRB	2021 Year 03 Month 11 Day
Anticipated trial start date	2021 Year 03 Month 18 Day
Last follow-up date	2021 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 16 Day
Last modified on	2022 Year 11 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049828