UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052782 |
|---|---|
| Receipt number | R000060210 |
| Scientific Title | Study on the Effect of Brazilian Green Propolis Consumption on Human Brown Fat and Energy Metabolism |
| Date of disclosure of the study information | 2023/11/13 |
| Last modified on | 2024/11/13 09:03:24 |
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Basic information
Public title
Study on the Effect of Green Propolis on Human Brown Fat
Acronym
Study on the Effect of Green Propolis on Human Brown Fat
Scientific Title
Study on the Effect of Brazilian Green Propolis Consumption on Human Brown Fat and Energy Metabolism
Scientific Title:Acronym
Study on the Effect of Brazilian Green Propolis Consumption on Human Brown Fat and Energy Metabolism
Region
| Japan |
Condition
Condition
Healthy male volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of Brazilian green propolis consumption on energy expenditure and body fat, and to determine its relationship with brown fat
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cold-induced thermogenesis (difference in oxygen consumption at room temperature of 27 degree and 19 degree) as an index of brown fat activity
Key secondary outcomes
(1) Change in body fat mass
(2) Change in body surface temperature during cold exposure
(3) Change in core body temperature during cold exposure
(4) Changes in the degree of fatty acid oxidation and carbohydrate oxidation
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Capsules containing 508 mg propolis were given daily for 4 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 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Those with body mass index from18.5 to 30.0
2. Those who provided informed consent forparticipation
Key exclusion criteria
1. Those who are receiving treatment, whether seasonal, chronic, or acute, by medication, therapy, or treatment
2. Those who have a history of asthma
3. Those who are allergic to bee products (such as honey), conifers, poplar, peruvian balsam (a resin obtained from pine trees in South America), or salicylic acid (included in anti-inflammatory medicines, therapeutics for wart, corn, etc.)
4. Those who will be taking other dietary supplements during the study period
5. Those who deemed ineligible by the Principal Investigator
Target sample size
16
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
Kita-ku N18 W9, Sapporo, Hokkaido
TEL
011-706-5205
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
Kita-ku N18 W9, Sapporo, Hokkaido
TEL
011-706-5205
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of NISHI-UMEDA Clinic for Asian Medical Collaboration
Address
3F Maruito Nishiumeda Build. 3-3-45 Umeda, Kita-ku, Osaka
Tel
06-4797-5660
jimukyoku@amc-clinc.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
| 2023 | Year | 11 | Month | 13 | 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
| 2023 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 13 | 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=R000060210
