UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056355 |
|---|---|
| Receipt number | R000064391 |
| Scientific Title | A study of how food with Brazilian green propolis affects energy metabolism. |
| Date of disclosure of the study information | 2024/12/04 |
| Last modified on | 2025/11/18 17:23:39 |
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Basic information
Public title
A study of how food with Brazilian green propolis affects energy metabolism.
Acronym
A study of how food with Brazilian green propolis affects energy metabolism.
Scientific Title
A study of how food with Brazilian green propolis affects energy metabolism.
Scientific Title:Acronym
A study of how food with Brazilian green propolis affects energy metabolism.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effects on energy metabolism of a test food containing Brazilian green propolis in healthy Japanese men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
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) Respiratory quotient
2) Carbohydrate oxidation rate
3) Fat oxidation rate
4) Change in body composition
5) Blood tests
6) Dietary survey
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Foods containing high-dose propolis
Daily intake: 566 mg
Duration: 84 days
Interventions/Control_2
Foods containing low-dose propolis
Daily intake: 566 mg
Duration: 84 days
Interventions/Control_3
placebo food
Daily intake: 566 mg
Duration: 84 days
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women aged more than 30 years, less than 65 years at the time of giving informed consent.
2) Those with body mass index from18.5 to 25.0.
3) Those who provided informed consent forparticipation.
4) Those with brown fat activity between 1.0 and 10.0.
Key exclusion criteria
1) Those who have a disorder to absorption, distribution, metabolism, excretion of food, such as digestive tract, liver, kidney, heart and cardiovascular system.
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 using or being treated with drugs that affect breath analysis, such as hay fever or chronic rhinitis medication.
5) Those with a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on (Excluding polypectomy and appendectomy).
6) Those who develop food allergies or other symptoms related to the test food, or who develop allergies or other symptoms when taking other supplements.
7) Be Suspected alcohol or drug dependence.
8) Those who meet the diagnostic criteria for metabolic syndrome.
9) Those taking medicines for glucose or lipid metabolism or antihypertensive drugs.
10) Those who routinely consume health foods containing propolis and black ginger, or functional foods and foods with functional claims and influences on lipid metabolism and body fat.
11) Those with a smoking habit of less than 10 years.
12) Those who participated in other clinical trial at resent (last 12 weeks).
13) Those who have donated 400 mL blood within the last 12 weeks, 200 mL blood within the last 4 weeks or component blood donations within the last 2 weeks from the date of consent.
14) Those with irregular lifestyles (e.g. night shift workers).
15) Those who wish to become pregnant, pregnant women or lactating women during the study period.
16) Those who will be taking other dietary supplements during the study period.
17) Those who deemed unsuitable for the study by the principal investigator.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kanaya |
Organization
Yamazaki Otolaryngology Clinic
Division name
chief director
Zip code
060-0011
Address
1-16,kita 11-jo,nishi 14-chome,chuo-ku,Sapporo-shi,Hokkaido 060-0011, Japan
TEL
011-757-3387
y-kohzai@kyowa-t.com
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Hyodo |
Organization
Yamada Bee Company, Inc.
Division name
Functional research section, Institute for Bee Products & Health Science R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393, Japan
TEL
0868-54-1199
Homepage URL
th2159@yamada-bee.com
Sponsor or person
Institute
KYOWA TRIAL CO., LTD
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
Institutional Review Board of Yamazaki Otolaryngology Vertigo Clinic
Address
14-1-16 Kita 11-jo Nishi, Chuo-ku, Sapporo-shi, Hokkaido 060-0011, Japan
Tel
011-757-3387
y-kohzai@kyowa-t.com
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
| 2024 | Year | 12 | Month | 04 | 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
| 2024 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 20 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064391
