UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of lipid metabolism-improving effects by taking a single dose of test beverage
Acronym	Evaluation of lipid metabolism-improving effects by taking a single dose of test beverage
Scientific Title	Evaluation of lipid metabolism-improving effects by taking a single dose of test beverage
Scientific Title:Acronym	Evaluation of lipid metabolism-improving effects by taking a single dose of test beverage
Region	Japan

Condition
Condition	Healthy male adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating some kind of improvement effect in lipid metabolism by ingesting a specified single dose of the test beverage to the subjects
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Respiratory quotient
Key secondary outcomes	1. Fat oxidation amount 2. Energy expenditure level

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	Consumption of the test beverage (500 mL) to the subject before starting the measurement of respiratory metabolism.
Interventions/Control_2	Consumption of the placebo beverage (500 mL) to the subject before starting the measurement of respiratory metabolism.
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	40 years-old >
Gender	Male
Key inclusion criteria	(1) Healthy male subjects ranging in age from 20 to 39. (2) Subjects who do not have a habit of exercises. (3) Subjects ranging in BMI from 18.5 to less than 25.0 kg/m2. (4) Subjects who can give informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects with previous and/or current medical history of serious diseases in circulatory/respiratory/digestive/urinary organs. (2) Throughout this trial, subjects who have any difficulty in refraining from taking steadily in the medicines (related to blood pressure, fatigue, lipid, and/or allergic rhinitis), which might affect the test results. (3) Subjects taking steadily in the following foods that might affect their test result; health-specific, functional, health foods (related to blood pressure, blood stream, exercise fatigue, metabolism-improving, poor blood flow-improving, fat combustion and/or lipolysis), supplementary one, vitamin tablet and nutrient, with any difficulty in refraining from having those during this trial. (4) Subjects who take excessive alcohol. (5) Subjects with any possibility of hindrance to this trial, owing to their allergic rhinitis. (6) Subjects who are now under the other clinical tests with some kind of medicine/food, or participated in those tests within four weeks before this trial. (7) Subjects falling into the habit of smoking. (8) Subjects suffering from severe anemia. (9) Subjects having drug and/or food allergy. (10) Subjects who donated over 200 mL of their whole blood and/or blood components within a month before this trial. (11) Subjects who donated over 400 mL of their whole blood within the last three months before this trial. (12) Subjects who will be collected over 1200 mL of their blood within the last twelve months before this trial. (13) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Fumiko Middle name Last name Nakamura
Organization	CPCC Company Limited
Division name	Clinical Support Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
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	Clinical Planning Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	ASAHI SOFT DRINKS 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 16 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 02 Month 08 Day
Date of IRB	2021 Year 02 Month 05 Day
Anticipated trial start date	2021 Year 02 Month 16 Day
Last follow-up date	2021 Year 05 Month 13 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 02 Month 15 Day
Last modified on	2022 Year 02 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049435