UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050784 |
|---|---|
| Receipt number | R000057735 |
| Scientific Title | Effects of propolis and exercise combined on energy metabolism |
| Date of disclosure of the study information | 2023/04/12 |
| Last modified on | 2023/09/29 14:23:22 |
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Basic information
Public title
Effects of propolis and exercise combined on energy metabolism
Acronym
Effects of propolis and exercise combined on energy metabolism
Scientific Title
Effects of propolis and exercise combined on energy metabolism
Scientific Title:Acronym
Effects of propolis and exercise combined on energy metabolism
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effect of Brazillian green propolis for healthy adults on energy metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Whole body energy expenditure assessed by 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
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 762 mg propolis were given daily for 8 days, and whole-body energy expenditure, respiratory quotient and adiposity were measured by indirect calorimetry at a resting state and exercise.
Interventions/Control_2
Placebo capsules were given daily for 8 days, and whole-body energy expenditure, respiratory quotient and adiposity were measured by indirect calorimetry at a resting state and exercise.
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy males of Japanese nationality between the ages of 18 and 30 with no exercise habits.
2) Subjects who can understand and comply with the rules written in protocol during the study period.
3) Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.
Key exclusion criteria
1) Subjects with diseases of the gastrointestinal tract, liver, kidney, heart, and circulatory system that affect absorption, distribution, metabolism, and excretion of the test food.
2) Subjects 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 (not including polypectomy and appendicectomy).
3) Subjects who has a history of seasonal allergies, perennial allergies, metal allergies, or asthma.
4) Subjects suspected of alcohol or drug dependence.
5) Subjects with problems with the diagnostic criteria for metabolic syndrome.
6) Subjects who taking medications (e.g., drugs for glucose or lipid metabolism, antihypertensive drugs, etc.).
7) Subjects who routinely consume health foods containing propolis or foods that affect lipid metabolism or body fat (including energy drinks and nutritional supplements).
8) Subjects who have a smoking habit (including e-cigarettes).
9) Subjects who another clinical trial or clinical research study within the past 84 days from the date consent was obtained.
10) Subjects who have donated 400 mL blood within the past 84 days, 200 mL blood within the past 28 days, or component blood donations (plasma and platelet components) within the past 14 days of obtaining consent.
11) Subjects who lead an irregular lifestyle (night shift workers, etc.)
12) Subjects who exercise on a daily basis (Subjects who have been performing light, sweaty exercise for at least 30 minutes a day, at least 2 days a week for at least 1 year.).
13) Subjects who may be exposed to extreme cold during the study period (e.g., travel to freezers or cold climates).
14) Subjects who are judged inappropriate as the subject by the subinvestigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Ritsumeikan university
Division name
Facuity of Sports and Health Science
Zip code
525-8577
Address
1-1-1 Noji-Higashi, Kusatsu, Shiga
TEL
077-599-4134
thashimo@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Ritsumeikan university
Division name
Facuity of Sports and Health Science
Zip code
525-8577
Address
1-1-1 Noji-Higashi, Kusatsu, Shiga
TEL
077-599-4134
Homepage URL
thashimo@fc.ritsumei.ac.jp
Sponsor or person
Institute
Institute
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 committee of Ritsumeikan University
Address
1-1-1 Noji-Higashi, Kusatsu, Shiga
Tel
077-599-4175
b-rinri@st.ritsumei.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
| 2023 | Year | 04 | Month | 12 | 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 | 03 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 08 | 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 | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057735
