UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043952 |
|---|---|
| Receipt number | R000050045 |
| Scientific Title | Chronic effects of green propolis ingestion on energy expenditure by brown adipose tissue in humans |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2024/11/13 09:04:19 |
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Basic information
Public title
Chronic effects of green propolis ingestion on energy expenditure by brown adipose tissue in humans
Acronym
Brown adipose tissue and green propolis
Scientific Title
Chronic effects of green propolis ingestion on energy expenditure by brown adipose tissue in humans
Scientific Title:Acronym
Brown adipose tissue and green propolis
Region
| Japan |
Condition
Condition
Healthy male volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the chronic effects of green propolis containing artepirin C as main component on energy expenditure and to analyze its relation to brown adipose tissue activity and adiposity in humans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Whole body energy expenditure assessed from respiratory gas analysis
Key secondary outcomes
respiratory quotient, adiposity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Capsules containing 543 mg propolis were given daily for 4-5 weeks, and whole-body energy expenditure, respiratory quotient and adiposity were measured by indirect calorimetry at a resting state and after 2-hr cold exposure.
Interventions/Control_2
Placebo capsules were given daily for 4-6 weeks, and whole-body energy expenditure, respiratory quotient and adiposity were measured by indirect calorimetry at a resting state and after 2-hr cold exposure.
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
| 35 | years-old | > |
Gender
Male
Key inclusion criteria
1.Healthy male volunteers
2. Aged 20-35 years
3. Those who is not receiving medical treatment with drugs, therapies, or operations for seasonal, chronic, or idiopathic disorders.
4. Those with body mass index from18.5 to 30.0
5. Those who provided informed consent for participation
Key exclusion criteria
Body mass index >=30
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Okamatsu |
Organization
Hokkaido University
Division name
Faculty of Veterinary Medicine
Zip code
060-0818
Address
Kita18 Nishi9, Kita-ku, Sapporo
TEL
0117065205
y-okamatsu@vetmed.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Okamatsu |
Organization
Hokkaido University
Division name
Faculty of Veterinary Medicine
Zip code
060-0818
Address
Kita18 Nishi9, Kita-ku, Sapporo
TEL
0117065205
Homepage URL
y-okamatsu@vetmed.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tenshi College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University
Address
Kita18 Nishi9, Kita-ku, Sapporo
Tel
011-706-5173
syomu@vetmed.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 31 | 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
15
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
| 2020 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 30 | 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 | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050045
