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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023753
Receipt No. R000027353
Scientific Title Effects of coingestion of glucose with protein and/or fat after exercise on insulin secretion
Date of disclosure of the study information 2016/08/27
Last modified on 2019/03/19

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Basic information
Public title Effects of coingestion of glucose with protein and/or fat after exercise on insulin secretion
Acronym Effects of coingestion of glucose with protein and/or fat after exercise on insulin secretion
Scientific Title Effects of coingestion of glucose with protein and/or fat after exercise on insulin secretion
Scientific Title:Acronym Effects of coingestion of glucose with protein and/or fat after exercise on insulin secretion
Region
Japan

Condition
Condition Normal
Classification by specialty
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of post-exercise ingestion of glucose in combination with milk, which contains the balanced protein and fat, on insulin secretion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Area under the curve for insulin level after ingestion of the test solution
Key secondary outcomes Blood glucose and GIP levels,
Ratings of perceived exertion

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Ergometer exercise(30min, 120-150bpm)> Blood sampling > Ingestion of a test solutionA > Blood samplings(15,30,60,120min after ingestion) > Ergometer exercise (30min, 120-150bpm) Blood sampling
All subjects will receive five treatments(test solution A-E) on five separate days over an interval of at least 6 days.
Interventions/Control_2 Ergometer exercise(30min, 120-150bpm)> Blood sampling > Ingestion of a test solutionB > Blood samplings(15,30,60,120min after ingestion) > Ergometer exercise (30min, 120-150bpm) Blood sampling
Interventions/Control_3 Ergometer exercise(30min, 120-150bpm)> Blood sampling > Ingestion of a test solutionC > Blood samplings(15,30,60,120min after ingestion) > Ergometer exercise (30min, 120-150bpm) Blood sampling
Interventions/Control_4 Ergometer exercise(30min, 120-150bpm)> Blood sampling > Ingestion of a test solutionD > Blood samplings(15,30,60,120min after ingestion) > Ergometer exercise (30min, 120-150bpm) Blood sampling
Interventions/Control_5 Ergometer exercise(30min, 120-150bpm)> Blood sampling > Ingestion of a test solutionE > Blood samplings(15,30,60,120min after ingestion) > Ergometer exercise (30min, 120-150bpm) Blood sampling
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
24 years-old >=
Gender Male and Female
Key inclusion criteria Healthy university students who have the exercise habit and have given written informed 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 20

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 Mizuno Sports Promotion Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor The University of Tokyo, Graduate School of Arts and Sciences, Department of Life Science
Name of secondary funder(s) Japan Table Tennis Association

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
2016 Year 08 Month 27 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
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
2016 Year 07 Month 07 Day
Date of IRB
2016 Year 08 Month 03 Day
Anticipated trial start date
2016 Year 08 Month 05 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 24 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=R000027353

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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