UMIN-CTR Clinical Trial

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
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	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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037090