UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035586 |
|---|---|
| Receipt number | R000040539 |
| Scientific Title | Enhancing effect of supplement on resting energy metabolism after single oral intake. -A randomized, double blind, placebo controlled, cross-over study- |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/08/06 15:40:56 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040539
