UMIN-CTR Clinical Trial

Basic information
Public title	Enhancing effect of supplement on resting energy metabolism after single oral intake. -A randomized, double blind, placebo controlled, cross-over study-
Acronym	Enhancing effect of supplement on resting energy metabolism after single oral intake.
Scientific Title	Enhancing effect of supplement on resting energy metabolism after single oral intake. -A randomized, double blind, placebo controlled, cross-over study-
Scientific Title:Acronym	Enhancing effect of supplement on resting energy metabolism after single oral intake.
Region	Japan

Condition
Condition	Adult males
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate enhancing effect of supplement on resting energy expenditure of subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Area under the curve for postprandial resting energy expenditure.
Key secondary outcomes	Area under the curve for oxygen consumption(VO2), carbon dioxide output(VCO2), fat oxidation(FOX), and carbohydrate oxdation(COX), and VO2, VCO2, EE, FOX, COX, respiratory quotient, heart rate, and LF/HF of before, 20, 60, 120, 180, 240, 300 minutes after breakfast.

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	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food, and then ingestion of placebo after wash out period.
Interventions/Control_2	Intake of placebo, and then ingestion of test food after wash out period.
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	65 years-old >
Gender	Male
Key inclusion criteria	1)Japanese males 20 to 64 years of age. 2)Body mass index >=18.5 kg/m2 and <25 kg/m2. 3)Subjects who have not performed regular exercise at least once a week with in the past year. 4)Subjects who are taking three meals a day (breakfast, lunch, dinner) on a daily basis. 5)Subjects who can life restrictions from two days before for date of admission to human calorie meter to the end of the examination. 6)Subjects who received a sufficient explanation about the purpose and content of this study and have a consent ability and volunteered to participate in the understanding and can agree to this study participation in writing.
Key exclusion criteria	1)Subjects who are undergoing medication suffer from some sort of disease. 2)Subjects who being irregular daily life such as shift worker or midnight work. 3)Subjects who have allergy to the test food or the provided meals and have potentially cause severe allergies to other foods and medicine. 4)Subjects who are likely to develop allergic rhinitis including pollinosis of moderate or higher symptoms during the study period. 5)Subjects who are plans to use medicines, quasi-drugs, food with health claims (food for specified health use), health foods and dietary supplements during the study period. 6)Subjects who have serious medical history or current medical history for liver, kidney, pancreas, heart, lung, circulatory organ, digestive organ, blood, metabolism. 7)Subjects whose HbA1c(NGSP) is more than 6.5 % 8)Subjects who have a habit of smoking. 9)Subjects who are ingesting alcohol in excessive (alcohol in terms of 60 g or more per day). 10)Subjects whose blood donation is more than 200 mL in the past one month or more than 400 mL in the past three months. 11)Subjects who have participated in other clinical trial or whose three months have not elapsed after joining other clinical trials or who have plans to participate in other clinical trials after consented to participation in this study. 12)Subjects who is considered to be inappropriate to attend the present study by the investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shukuko Middle name Last name Ebihara
Organization	Chiyoda Paramedical Care Clinic
Division name	Director
Zip code	101-0047
Address	2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-5548
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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	チヨダパラメディカルケアクリニック（東京都）、富士医科産業株式会社テクニカルセンター（千葉県）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 01 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	20
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	2019 Year 01 Month 09 Day
Date of IRB	2019 Year 01 Month 11 Day
Anticipated trial start date	2019 Year 04 Month 05 Day
Last follow-up date	2019 Year 07 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 18 Day
Last modified on	2019 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040539