UMIN-CTR Clinical Trial

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 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
Email	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
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	Takasaki University of Health and Welfare
Address	37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan
Tel	027-352-1290
Email	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	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	Terminated
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	2020 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027353