UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023753 |
|---|---|
| Receipt number | R000027353 |
| Scientific Title | Effects of coingestion of glucose with protein and/or fat after exercise on insulin secretion |
| Date of disclosure of the study information | 2016/08/27 |
| Last modified on | 2020/08/27 09:18:49 |
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Basic information
Public title
Effects of coingestion of glucose with protein and/or fat after exercise on insulin secretion
Acronym
Effects of coingestion of glucose with protein and/or fat after exercise on insulin secretion
Scientific Title
Effects of coingestion of glucose with protein and/or fat after exercise on insulin secretion
Scientific Title:Acronym
Effects of coingestion of glucose with protein and/or fat after exercise on insulin secretion
Region
| Japan |
Condition
Condition
Normal
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of post-exercise ingestion of glucose in combination with milk, which contains the balanced protein and fat, 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
5
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Ergometer exercise(30min, 120-150bpm)> Blood sampling > Ingestion of a test solutionA > Blood samplings(15,30,60,120min after ingestion) > Ergometer exercise (30min, 120-150bpm) Blood sampling
All subjects will receive five treatments(test solution A-E) on five separate days over an interval of at least 6 days.
Interventions/Control_2
Ergometer exercise(30min, 120-150bpm)> Blood sampling > Ingestion of a test solutionB > Blood samplings(15,30,60,120min after ingestion) > Ergometer exercise (30min, 120-150bpm) Blood sampling
Interventions/Control_3
Ergometer exercise(30min, 120-150bpm)> Blood sampling > Ingestion of a test solutionC > Blood samplings(15,30,60,120min after ingestion) > Ergometer exercise (30min, 120-150bpm) Blood sampling
Interventions/Control_4
Ergometer exercise(30min, 120-150bpm)> Blood sampling > Ingestion of a test solutionD > Blood samplings(15,30,60,120min after ingestion) > Ergometer exercise (30min, 120-150bpm) Blood sampling
Interventions/Control_5
Ergometer exercise(30min, 120-150bpm)> Blood sampling > Ingestion of a test solutionE > Blood samplings(15,30,60,120min after ingestion) > Ergometer exercise (30min, 120-150bpm) Blood sampling
Interventions/Control_6
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 the exercise habit and 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 had a food-dependent exercise-induced anaphylaxis
6)who are judged as ineligible by the doctor for other reasons
Target sample size
20
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
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
kimura@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Mizuno Sports Promotion Foundation
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)
Japan Table Tennis Association
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
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
| 2016 | Year | 08 | Month | 27 | 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
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
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 24 | Day |
Last modified on
| 2020 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027353
