UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000033591
Receipt No. 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 (Ver. 4)

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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
Last 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
Email m.shibasaki@thu.ac.jp

Public contact
1st 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
Email m.shibasaki@thu.ac.jp

Sponsor
Institute Teikyo Heisei University
Department of Health and Dietetics
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038309