UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018343 |
|---|---|
| Receipt number | 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 10:06:36 |
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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
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
Kunpei-tanisawa@fuji.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021113
