UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of coingestion of glucose with milk after exercise on insulin secretion
Title of the study (Brief title)	Effects of coingestion of glucose with milk after exercise on insulin secretion
Region	Japan

Condition
Condition	Nomal
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of post-exercise ingestion of glucose with milk 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	2
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Ergometer exercise(30min, 120-130bpm)> Blood sampling > Ingestion of a control solution > Blood samplings(15,30,60,120min after ingestion)
Interventions/Control_2	Ergometer exercise(30min, 120-130bpm)> Blood sampling > Ingestion of a test solution > Blood samplings(15,30,60,120min after ingestion)
Interventions/Control_3
Interventions/Control_4
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	24 years-old >=
Gender	Female
Key inclusion criteria	Healthy female university students who 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 are judged as ineligible by the doctor for other reasons
Target sample size	10

Research contact person
Name of lead principal investigator	Michiyo Kimura
Organization	Takasaki University of Health and Welfare
Division name	Health and Welfare
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	Michiyo Kimura
Organization	Takasaki University of Health and Welfare
Division name	Health and Welfare
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	J-milk (Japan Dairy Association)
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)

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 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 10 Day
Anticipated trial start date	2015 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 28 Day
Last modified on	2016 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027415