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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018343
Receipt No. R000021113
Scientific Title Does the pre-exercise ingestion of carbohydrate really cause transient hypoglycemia during exercise?
Date of disclosure of the study information 2015/08/01
Last modified on 2018/04/25

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Basic information
Public title Does the pre-exercise ingestion of carbohydrate really cause transient hypoglycemia during exercise?
Acronym Pre-exercise ingestion of carbohydrate and transient hypoglycemia.
Scientific Title Does the pre-exercise ingestion of carbohydrate really cause transient hypoglycemia during exercise?
Scientific Title:Acronym 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
1st name
Middle name
Last name Mitsuru Higuchi
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL 04-2947-6745
Email mhiguchi@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kumpei Tanisawa
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
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)

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
2015 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2015 Year 07 Month 20 Day
Date of IRB
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

Other
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

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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