UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049142 |
|---|---|
| Receipt number | R000055975 |
| Scientific Title | A study to investigate the effects of supplementation of botanical extract on muscular hypertrophy with resistance training: a randomized, double-blind, placebo controlled, parallel-group comparative study. |
| Date of disclosure of the study information | 2022/12/30 |
| Last modified on | 2022/12/19 09:00:04 |
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Basic information
Public title
A study to investigate the effects of supplementation of botanical extract on muscular hypertrophy with resistance training: a randomized, double-blind, placebo controlled, parallel-group comparative study.
Acronym
A study to investigate the effects of supplementation of botanical extract on muscular hypertrophy with resistance training.
Scientific Title
A study to investigate the effects of supplementation of botanical extract on muscular hypertrophy with resistance training: a randomized, double-blind, placebo controlled, parallel-group comparative study.
Scientific Title:Acronym
A study to investigate the effects of supplementation of botanical extract on muscular hypertrophy with resistance training.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effects of orally administrated botanical extract on muscular hypertrophy with muscle training in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal muscle mass
Key secondary outcomes
Muscle strength
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food containing lemon myrtle extract for 12 or 16 weeks.
Resistance training for 8weeks.
Interventions/Control_2
Intake of placebo food not containing lemon myrtle extract for 12 or 16 weeks.
Resistance training for 8weeks.
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.Subjects who are over 18 years old, healthy males and students of Nippon sport science university.
2.Subjects who don't do dumbbell curl on daily baisis.
Key exclusion criteria
1. Subjects who intake supplements or functional foods as sports nutrition on a daily basis.
2. Subjects with symptoms that interfere with training, such as arthralgia, bone disease.
3. Subjects who have illness or medical history such as high blood pressure, heart disease.
4. Subjects who is ineligible due to physician's judgment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mikako |
| Middle name | |
| Last name | Sunaga |
Organization
Nippon Sport Science University
Division name
Department of Childhood Sport Education
Zip code
1588508
Address
7-1-1Fukasawa, Setagaya-ku, Tokyo, Japan
TEL
03-5706-1360
sunaga@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Mikako |
| Middle name | |
| Last name | Sunaga |
Organization
Nippon Sport Science University
Division name
Department of Childhood Sport Education
Zip code
1588508
Address
7-1-1Fukasawa, Setagaya-ku, Tokyo, Japan
TEL
03-5706-1360
Homepage URL
sunaga@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Funding Source
Organization
Keneka corporation
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
Nippon Sport Science University
Address
7-1-1Fukasawa, Setagaya-ku, Tokyo, Japan
Tel
03-5706-0931
souspo@nittai.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 | 12 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055975
| 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 |
