UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033591 |
|---|---|
| Receipt number | R000038309 |
| Scientific Title | The effect of dietary supplement on physical condition in long distance runners. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/03/29 17:19:58 |
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Basic information
Public title
The effect of dietary supplement on physical condition in long distance runners.
Acronym
The effect of dietary supplement on physical condition in long distance runners.
Scientific Title
The effect of dietary supplement on physical condition in long distance runners.
Scientific Title:Acronym
The effect of dietary supplement on physical condition in long distance runners.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of dietary supplement on physical condition in long distance runners.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Chalder fatigue scale
Key secondary outcomes
ferritin, UIBC, TIBC, Fe, RBC, Ht, Hb, MCHC, MCH, MCV, WBC, Plt, prealbmin, CK, VAS questionnaire assessed fatigue , brief-type self-administered diet history questionnaire,body weight, body mass index, body fat percentage, body fat mass, muscle mass, extensional brachial circumference, elbow flexion position circumference, maximum forearm circumference, minimum forearm circumference, the femoral circumference of 10 cm proximal to the upper edge of patella, the femoral circumference of 15 cm proximal to the upper edge of patella, maximum limb circumference, minimum limb circumference,grip strength, tongue pressure,questionnaire assessed impression after ingesting test food, diary-test food data (number of days on which test food not ingested. etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily intake of 150g of dietary supplement for 1 month.
Interventions/Control_2
No intervention
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
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Subjects giving written informed consent.
2. Subjects belong to the track and field club of Teikyo Heisei University.
Key exclusion criteria
1.Subjects who is being serious or progressive diseases.
2.Subjects who currently participate in other clinical studies.
3.Subjects who are judged unsuitable for this study by the principal investigator or the research physician.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Motomi |
| Middle name | |
| Last name | Shibasaki |
Organization
Teikyo Heisei University
Division name
Department of Health and Dietetics
Zip code
170-8445
Address
2-51-4 Higashi-Ikebukuro, Toshima, Tokyo,170-8445,Japan
TEL
03-5843-4822
m.shibasaki@thu.ac.jp
Public contact
Name of contact person
| 1st name | Motomi |
| Middle name | |
| Last name | Shibasaki |
Organization
Teikyo Heisei University
Division name
Department of Health and Dietetics
Zip code
170-8445
Address
2-51-4 Higashi-Ikebukuro, Toshima, Tokyo,170-8445,Japan
TEL
03-5843-4822
Homepage URL
m.shibasaki@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Department of Health and Dietetics
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo Heisei University Ethical Committee
Address
2-51-4 Higashi-Ikebukuro, Toshima, Tokyo,170-8445,Japan
Tel
03-5843-3111
rec@thu.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
帝京平成大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | 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
20
Results
Dairy intake of dietary supplement caused decreasing of fatigue in long-distance runners.
The decline was obvious, especially after intensive bout of exercise during training camp.
The skeletal muscle mass tended to increase only after the camp.
Results date posted
| 2019 | Year | 03 | Month | 29 | Day |
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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 08 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 19 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038309
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| Registered date | File name |
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