UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Does the pre-exercise ingestion of carbohydrate really cause transient hypoglycemia during exercise?
Title of the study (Brief title)	Pre-exercise ingestion of carbohydrate and transient hypoglycemia.
Region	Japan

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

Objectives
Narrative objectives1	To examine the pre-endurance exercise ingestion of carbohydrate causes exercise- and insulin-induced hypoglycemia "insulin shock" in Japanese individuals.
Basic objectives2	Others
Basic objectives -Others	To examine the effects of absence of breakfast in the morning of experiments, carbohydrate dose, and characteristics of subjects on the incidence of insulin shock.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Plasma glucose concentration and serum insulin concentration (measured at 30 min before the start of exercise, just before the start of exercise, 15 min after the start of exercise, 30 min after the start of exercise, 60 min after the start of exercise, immediately after the endurance exercise performance test). Endurance exercise performance (measured at immediately after the 60 min exercise).
Key secondary outcomes	Serum free fatty acid concentration, serum glycerol concentration, blood lactate concentration, red blood cell count, hemoglobin concentration, hematocrit, white blood cell count and differential, serum interleukin-6 concentration, plasma catecholamine concentration and differential, serum cortisol concentration, serum growth hormone concentration (measured at 30 min before the start of exercise, just before the start of exercise, 15 min after the start of exercise, 30 min after the start of exercise, 60 min after the start of exercise, immediately after the endurance exercise performance test). Respiratory exchange ratio, rate of perceived exertion (measured at 15 min after the start of exercise, 30 min after the start of exercise, 45 min after the start of exercise. 60 min after the start of 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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	10
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Period: four days Factor A: glucose solution Factor B: breakfast intake Dose (factor A): 150g glucose Dose (factor B): 700kcal meal Time, frequency: once per experiment 150g glucose (no breakfast)>wash-out (1 week)>150g glucose (eating breakfast)>wash-out (1 week)>placebo (no breakfast)>wash-out (1 week)>placebo (eating breakfast)
Interventions/Control_2	Period: four days Factor A: glucose solution Factor B: breakfast intake Dose (factor A): 150g glucose Dose (factor B): 700kcal meal Time, frequency: once per experiment 150g glucose (eating breakfast)>wash-out (1 week)>150g glucose (no breakfast)> wash-out(1 week)>placebo (eating breakfast)>wash-out (1 week)>placebo (no breakfast)
Interventions/Control_3	Period: four days Factor A: glucose solution Factor B: breakfast intake Dose (factor A): 150g glucose Dose (factor B): 700kcal meal Time, frequency: once per experiment 150g glucose (no breakfast)>wash-out (1 week)>placebo (eating breakfast)>wash-out (1 week)>placebo (no breakfast)>wash-out (1 week)>150g glucose (eating breakfast)
Interventions/Control_4	Period: four days Factor A: glucose solution Factor B: breakfast intake Dose (factor A): 150g glucose Dose (factor B): 700kcal meal Time, frequency: once per experiment 150g glucose (eating breakfast)>wash-out (1 week)>placebo (no breakfast)>wash-out (1 week)>placebo (eating breakfast)>wash-out (1 week)>150g glucose (no breakfast)
Interventions/Control_5	Period: four days Factor A: glucose solution Factor B: breakfast intake Dose (factor A): 150g glucose Dose (factor B): 700kcal meal Time, frequency: once per experiment placebo (no breakfast)>wash-out (1 week)>placebo (eating breakfast)>wash-out (1 week)>150g glucose (no breakfast)>wash-out (1 week)>150g glucose (eating breakfast)
Interventions/Control_6	Period: four days Factor A: glucose solution Factor B: breakfast intake Dose (factor A): 150g glucose Dose (factor B): 700kcal meal Time, frequency: once per experiment placebo (eating breakfast)>wash-out (1 week)>placebo (no breakfast)>wash-out (1 week)>150g glucose (eating breakfast)>wash-out (1 week)>150g glucose (no breakfast)
Interventions/Control_7	Period: four days Factor A: glucose solution Factor B: breakfast intake Dose (factor A): 150g glucose Dose (factor B): 700kcal meal Time, frequency: once per experiment placebo (no breakfast)>wash-out (1 week)>150g glucose (eating breakfast)>wash-out (1 week)>150g glucose (no breakfast)>wash-out (1 week)>placebo (eating breakfast)
Interventions/Control_8	Period: four days Factor A: glucose solution Factor B: breakfast intake Dose (factor A): 150g glucose Dose (factor B): 700kcal meal Time, frequency: once per experiment placebo (eating breakfast)>wash-out (1 week)>150g glucose (no breakfast)>wash-out (1 week)>150g glucose (eating breakfast)>wash-out (1 week)>placebo (no breakfast)
Interventions/Control_9	eriod: four days Factor A: glucose solution Factor B: breakfast intake Dose (factor A): 150g glucose Dose (factor B): 700kcal meal Time, frequency: once per experiment 150g glucose (no breakfast)>wash-out (1 week)>placebo (no breakfast)>wash-out (1 week)>150g glucose (eating breakfast)>wash-out (1 week)>placebo (eating breakfast)
Interventions/Control_10	Period: four days Factor A: glucose solution Factor B: breakfast intake Dose (factor A): 150g glucose Dose (factor B): 700kcal meal Time, frequency: once per experiment placebo (no breakfast)>wash-out (1 week)>150g glucose (no breakfast)>wash-out (1 week)>placebo (eating breakfast)>wash-out (1 week)>150g glucose (eating breakfast)

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	29 years-old >=
Gender	Male
Key inclusion criteria	Endurance athletes Healthy men
Key exclusion criteria	Subject who could not perform exercise and/or who have chronic diseases
Target sample size	20

Research contact person
Name of lead principal investigator	Mitsuru Higuchi
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL	04-2947-6745
Email	mhiguchi@waseda.jp

Public contact
Name of contact person	Kumpei Tanisawa
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL	04-2947-6833
Homepage URL
Email	Kunpei-tanisawa@fuji.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2015 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 20 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 17 Day
Last modified on	2018 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021113