UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015237 |
|---|---|
| Receipt number | R000017713 |
| Scientific Title | Study of the effects of propolis intake on physical fitness. (clinical trial) |
| Date of disclosure of the study information | 2014/09/24 |
| Last modified on | 2014/09/24 14:51:55 |
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Basic information
Public title
Study of the effects of propolis intake on physical fitness. (clinical trial)
Acronym
Study of the effects of propolis intake on physical fitness. (clinical trial)
Scientific Title
Study of the effects of propolis intake on physical fitness. (clinical trial)
Scientific Title:Acronym
Study of the effects of propolis intake on physical fitness. (clinical trial)
Region
| Japan |
Condition
Condition
Healthy men and women
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of 3-month propolis intake and walking on physical strength and health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body measurement, intima-media, thickness, pulse wave velocity, analysis of expired gas, heart rate, blood pressure
Key secondary outcomes
Questionnaire, diary
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Oral intake of 3 capsules containing 75.6 mg propolis extract and 30-minute walk 3 times a week for first-3 months and only 30-minute walk for the next-3 months.
Interventions/Control_2
Oral intake of 3 capsules containing 75.6 mg propolis extract for 3 months.
Interventions/Control_3
30-minute walk 3 times a week for 3 months.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged from 40 to 65 years.
2. Subjects who are usually sedentary.
Key exclusion criteria
1. Subjects with food allergies.
2. Subjects who consume medicinal product which may influence the outcome of the study.
3. Subjects who consume health food which may influence the outcome of the study.
4. Subjects who are pregnant or lactating.
5. Subjects with severe dysfunction of liver, kidney, heart, blood, urological or gynecological.
6. Subjects who participate in other clinical study.
7. Subjects who are judged as unsuitable for the study by the investigator for the other reason.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Kawakami |
Organization
Kurashiki University of Science and The arts.
Division name
Major of Health and Sports Science, College of Life Science
Zip code
Address
2640 Nishinoura Tsurajima-cho Kurashiki Okayama, 712-8505, Japan
TEL
086-440-1173
masa-k@ms.kusa.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Kawakami |
Organization
Kurashiki University of Science and The art.
Division name
Major of Health and Sports Science, College of Life Science
Zip code
Address
2640 Nishinoura Tsurajima-cho Kurashiki Okayama, 712-8505, Japan
TEL
086-440-1173
Homepage URL
masa-k@ms.kusa.ac.jp
Sponsor or person
Institute
Major of Health and Sports Science, College of Life Science, Kurashiki University of Science and The arts.
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
Address
Tel
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
倉敷芸術科学大学（岡山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 24 | Day |
Last modified on
| 2014 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017713
| Research Plan | |
|---|---|
| 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 |
