UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034073 |
|---|---|
| Receipt number | R000038840 |
| Scientific Title | Exploratory test on the influence of food intake on exercise performance and fatigue reduction effects during endurance exercise |
| Date of disclosure of the study information | 2018/09/10 |
| Last modified on | 2019/03/12 10:56:46 |
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Basic information
Public title
Exploratory test on the influence of food intake on exercise performance and fatigue reduction effects during endurance exercise
Acronym
Exploratory test on the influence of food intake on exercise performance
Scientific Title
Exploratory test on the influence of food intake on exercise performance and fatigue reduction effects during endurance exercise
Scientific Title:Acronym
Exploratory test on the influence of food intake on exercise performance
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Explore the influence of food intake on exercise performance and fatigue reduction effects during endurance exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chang of blood glucose level during endurance exercise
Key secondary outcomes
General blood biochemical test (total protein, albumin, total cholesterol, blood neutral fat (TG), HDL-cholesterol, LDL-cholesterol, AST(GOT), ALT(GPT), ALP, gamma-GTP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, potassium, chlorine, calcium, phosphorus, LDH, HbA1c), blood test (lactic acid, insulin, 8-OHdG, TNF-alpha, IL-6, IL-8, IL-10), Saliva test (alpha-amylase, cortisol, IL-6), physical examination (body weight, blood pressure, pulse rate, BMI, body fat percentage), questionnaire on lifestyle habit and on fatigue at the beginning of and after exercise, and maximal oxygen uptake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest total 234 g of banana before exercise
Interventions/Control_2
Ingest total 53.3 g of maltodextrin before exercise
Interventions/Control_3
Ingest total 150 g of rice before exercise
Interventions/Control_4
Ingest total 113 g of bread before exercise
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who are 20 years old or more and under 40 years old
3. Persons who have confidence to possess physical fitness to withstand exercise stress test
Key exclusion criteria
1. Persons who have a chronic disease and is under medication, or has a serious disease history
2. Persons who are allergic to the test food
3. Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement
4. Persons who are judged inappropriate for the exam by the principal investigator
5. Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period
6. Persons who are prohibited from exercising by the doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamasa Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development
Zip code
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamasa Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development
Zip code
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
SOLROS 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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 10 | 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
| 2018 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038840
