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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032533
Receipt No. 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 2019/03/19

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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
Middle name
Last name Michiyo Kimura
Organization Takasaki University of Health and Welfare
Division name Health and Welfare
Zip code
Address 37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan
TEL 027-352-1290
Email kimura@takasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michiyo Kimura
Organization Takasaki University of Health and Welfare
Division name Health and Welfare
Zip code
Address 37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan
TEL 027-352-1290
Homepage URL
Email kimura@takasaki-u.ac.jp

Sponsor
Institute Takasaki University of Health and Welfare
Institute
Department

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
Address
Tel
Email

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 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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 09 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037090

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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