UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052890 |
|---|---|
| Receipt number | R000059654 |
| Scientific Title | Study of the effect of Oligonol on the performance of long distance runners. |
| Date of disclosure of the study information | 2023/12/07 |
| Last modified on | 2024/05/07 09:18:49 |
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Basic information
Public title
Study of the effect of Oligonol on the performance of long distance runners.
Acronym
Study of the effect of Oligonol on the performance of long distance runners.
Scientific Title
Study of the effect of Oligonol on the performance of long distance runners.
Scientific Title:Acronym
Study of the effect of Oligonol on the performance of long distance runners.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Long distance runners were given Oligonol(R) 200 mg/day or placebo for 60 days, and their 10 km running time before and after intake, subjective exercise strength (RPE) immediately after running, and physical condition were evaluated to clarify the effect of Oligonol(R) in improving exercise performance during long distance running. and physical condition before and after ingestion of Oligonol(R).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time for the 10 km run
Key secondary outcomes
Rate of Perceived Exertion (RPE)
Physical condition (VAS: Visual Analog Scale)
Post-exercise body composition measurement: body weight, muscle mass, body fat mass, etc.
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
- Test product: Hard capsules (Suheung, size 1, brown, transparent, derived from porcine gelatin) containing Oligonol(R)
- Dosage and administration: Oligonol(R) 100 mg or placebo, one capsule each after breakfast and dinner, total 2 capsules (200 mg)/day
- Duration of intake: 60 days
Interventions/Control_2
- Test food: Hard capsules (Suheung, size 1, brown, transparent, derived from porcine gelatin) containing maltz extract (placebo)
- Dosage and administration: 1 capsule of placebo after breakfast and dinner, for a total of 2 capsules/day
- Duration of intake: 60 days
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult men and women who have a daily exercise habit
The subjects must agree to the following three conditions regarding the use of dietary supplements during the study period
1. Do not use polyphenols or other supplements that may affect the study
2. Continue intake of supplements currently being used
3. Do not start a new supplement
Key exclusion criteria
- Persons with serious illnesses
- Pregnant, possibly pregnant, or lactating
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Takanari |
Organization
Amino Up Co., Ltd.
Division name
Business Development Division Academic Affairs
Zip code
004-0839
Address
363-32 Shinei, Kiyota, Sapporo, Hokkaido, JAPAN
TEL
0118892555
takanari@aminoup.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Shio |
Organization
Amino Up Co., Ltd.
Division name
Business Development Division Academic Affairs
Zip code
0040839
Address
363-32 Shinei, Kiyota, Sapporo, Hokkaido, JAPAN
TEL
09070501833
Homepage URL
shio@aminoup.jp
Sponsor or person
Institute
Amino Up Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Amino Up Co., Ltd.
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
NPO corporation Hokkaido activation center TACTICS Ethics Committee
Address
5F, Infas, Kita 2-jo Nishi 9-chome, Chuo-ku, Sapporo, Hokkaido 060-0002, Japan
Tel
0116628591
yuriko.iw@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2023172
Org. issuing International ID_1
NPO corporation Hokkaido activation center TACTICS Ethics Committee
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 | 12 | Month | 07 | 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 | 30 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 07 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059654
