UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032533 |
|---|---|
| Receipt number | R000037090 |
| Scientific Title | Effect of ingesting the beverages with different contents of carbohydrate and fat on exercise performance in the well-trained university students |
| Date of disclosure of the study information | 2018/05/10 |
| Last modified on | 2019/11/10 12:58:36 |
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Basic information
Public title
Effect of ingesting the beverages with different contents of carbohydrate and fat on exercise performance in the well-trained university students
Acronym
Effect of ingesting the beverages with different contents of carbohydrate and fat on exercise performance
Scientific Title
Effect of ingesting the beverages with different contents of carbohydrate and fat on exercise performance in the well-trained university students
Scientific Title:Acronym
Effect of ingesting the beverages with different contents of carbohydrate and fat on exercise performance
Region
| Japan |
Condition
Condition
Normal
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effets of ingesting the beverages with different contents of carbohydrate and fat on exercise performance and insulin secretion in the well-trained university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Stroop test during cycle ergometer exercise
2.Area under the curve for insulin level after ingestion of the test solution
Key secondary outcomes
1.Blood glucose levels after ingestion of the test solution
2.Glucose-dependent insulinotropic polypeptide (GIP)level after ingestion of the test solution
3.Rating of perceived exertion during cycle ergometer exercise
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
6
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test A solution(CHO 0.5g/kg body weight+250mL Water)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.
All subjects will receive 6 treatments(test solution A-F) on 6 separate days over an interval of at least 6 days.
Interventions/Control_2
Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test B solution(CHO 0.5g/kg body weight+250mL Milk)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.
Interventions/Control_3
Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test C solution(CHO 0.5g/kg body weight+250mL High fat milk)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.
Interventions/Control_4
Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test D solution(CHO 1.0g/kg body weight+250mL Water)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.
Interventions/Control_5
Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test E solution(CHO 1.0g/kg body weight+250mL Milk)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.
Interventions/Control_6
Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test F solution(CHO 1.0g/kg body weight+250mL High fat milk)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy university students who have th
e exercise habit and have given written i
nformed consent
Key exclusion criteria
Subjects
1)who have heart disease and/or respiratory disease and/or injury
2)who having take medicine
3)with food allergies
4)who having a smoking habit
5)who had a food-dependent exercise-induced anaphylaxis
6)who are judged as ineligible by the doctor for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Health and Welfare
Zip code
3700033
Address
37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan
TEL
027-352-1290
kimura@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Health and Welfare
Zip code
3700033
Address
37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan
TEL
027-352-1290
Homepage URL
kimura@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Health and Welfare
Address
37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan
Tel
027-352-1290
mune@takasaki-u.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
| 2018 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
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 | 04 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 09 | Day |
Last modified on
| 2019 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037090
