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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037196
Receipt No. R000042404
Scientific Title An evaluation study for fat metabolism improving effect by single consumption of test beverage
Date of disclosure of the study information 2020/06/29
Last modified on 2019/06/27

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Basic information
Public title An evaluation study for fat metabolism improving effect by consumption of test food
Acronym An evaluation study for fat metabolism improving effect by consumption of test food
Scientific Title An evaluation study for fat metabolism improving effect by single consumption of test beverage
Scientific Title:Acronym An evaluation study for fat metabolism improving effect by consumption of test food
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is dose setting of test food, for evaluation of fat metabolism improving effect by consumption of test food.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Respiration quotient
Key secondary outcomes Fat oxidation
Energy expenditure
Incidence of adverse events and of side effects

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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test food A just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of test food B just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of control food just before measuring metabolism by exhalation.
Interventions/Control_2 Intake of test food B (200mL) just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of control food just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of test food A just before measuring metabolism by exhalation.
Interventions/Control_3 Intake of control food just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of test food A just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of test food B just before measuring metabolism by exhalation.
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) Healthy males aged 20 to 39 years old.
2) Males whose have no custom of exercise.
3) Males whose BMI ranges from 18.5 to 25.0
4) Males who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria 1) Males who have previous and/or current medical history of serious disease (e.g., circulatory organs, respiratory organs, digestive organs, urinary organs and endocrine organs).
2) Males who constantly use or who can't restrict use oral medicines (related to blood pressure, fatigue and fat metabolism) having a possibility of affecting test results.
3) Males who constantly use or who can't restrict use supplements, vitamins and nutrient (related to blood pressure, blood flow, exercise fatigue, metabolic improvement, fat burning or lipolysis) having a possibility of affecting test results.
4) Males who excessive alcohol intake.
5) Males who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study.
6) Males who have smoking habit.
7) Males who are severe anemia
8) Males who have previous medical history of drug and/or food allergy.
9) Males who donated over 200mL blood and/or blood components within the last one month to this study.
10) Males who donated over 400mL blood and/or blood components within the last three month to this study.
11) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
12) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Suguru
Middle name
Last name Fujiwara
Organization CPCC Company Limited
Division name Division of Clinical Research
Zip code 101-0047
Address 4F Sanwauchikannda Building, 3-3-5 Uchikanda 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 Planning & Sales Department
Zip code 101-0047
Address 4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization ASAHI QUALITY & INNOVATIONS, 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 Sanwauchikannda 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

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 29 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 Preinitiation
Date of protocol fixation
2019 Year 06 Month 21 Day
Date of IRB
2019 Year 06 Month 21 Day
Anticipated trial start date
2019 Year 06 Month 29 Day
Last follow-up date
2019 Year 10 Month 27 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 06 Month 27 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042404

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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