UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038121 |
|---|---|
| Receipt number | R000043426 |
| Scientific Title | Effects of Capsicum ingredient intake on energy metabolism and brown adipose tissue density |
| Date of disclosure of the study information | 2019/11/17 |
| Last modified on | 2020/03/27 11:07:10 |
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Basic information
Public title
Effects of Capsicum ingredient intake on energy metabolism and brown adipose tissue density
Acronym
Effects of Capsicum ingredient intake on energy metabolism and brown adipose tissue density
Scientific Title
Effects of Capsicum ingredient intake on energy metabolism and brown adipose tissue density
Scientific Title:Acronym
Effects of Capsicum ingredient intake on energy metabolism and brown adipose tissue density
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine changes in resting energy consumption, brown adipose tissue density, visceral fat area, body composition, chill, and vigor/fatigue tiredness induced by Capsicum ingredient intake in middle and elderly men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in resting energy rate and brown adipose tissue density after 6 weeks
Key secondary outcomes
1) Changing body composition (body temperature, fat area)
2) Oxygen consumption
3) Questionnaire on life style and actual feeling
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
Healthy volunteers are given a Capsicum ingredient (9.0 mg/day) supplement every day for 6 weeks.
Interventions/Control_2
Healthy volunteers are given a placebo supplement every day for 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
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Subjects who have will to follow the experimental design and get agreement on participation.
2) Subjects who can come to Tokyo Medical University where conduct examination.
3) Subjects who have a body mass index (BMI) of 23-28 kg/m2.
4) Subjects who can ingest a capsule.
Key exclusion criteria
1) Subjects who routinely intake nutritional foods and/or supplements such as catechin, sesamin, and capsaicin of which usefulness for energy metabolism have been reported.
2) Subjects who routinely take medicine such as coenzyme Q10 and adenosine triphosphate which have an effect on energy metabolism.
3) Subjects who routinely intake nutritional foods and/or supplements such as monoglucosyl hesperidin and shogaol of which usefulness for maintenance of body temperature have been reported.
4) Subjects with extremely higher than 100 micromol/L of total-hemoglobin concentration in tissue in the supraclavicular region which is index of brown adipose tissue density whose increase energy metabolism.
5) Subjects who have been diagnosed with obesity.
6) Subjects with a disease causing hyperthyroidism.
7) Subjects who are judge as unsuitable for the study by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Hamaoka |
Organization
Tokyo Medical University
Division name
Department of Sports Medicine for Health Promotion
Zip code
160-8402
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo Japan
TEL
03-3351-6141
hamaoka@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Fuse |
Organization
Tokyo Medical University
Division name
Department of Sports Medicine for Health Promotion
Zip code
160-8402
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo Japan
TEL
03-3351-6141
Homepage URL
fuse@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Sports Medicine for Health Promotion, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
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
Center for Research Administration and Innovation, Tokyo Medical University
Address
6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo Japan
Tel
03-3342-6111
IRB@tokyo-med.ac.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
東京医科大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | 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
| 2019 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The title at Ethical appraisal is different from the registration title of this time due to patent applications.
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043426
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
