UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030470 |
|---|---|
| Receipt number | R000034792 |
| Scientific Title | The effects of exercise on gastric emptying and energy intake |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2019/06/22 12:18:32 |
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Basic information
Public title
The effects of exercise on gastric emptying and energy intake
Acronym
The effects of exercise on gastric motility and appetite
Scientific Title
The effects of exercise on gastric emptying and energy intake
Scientific Title:Acronym
The effects of exercise on gastric motility and appetite
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of exercise on gastric emptying rate after ingesting drink and subsequent appetite.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Postprandial cross sectional antral area of stomach.
2) Active ghrelin, peptide YY, cholecystokinin
3) Energy intake
Key secondary outcomes
1) Blood parameters
2) Subjective hunger by visual analogue scale (VAS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants rested over 60 min. Then, postprandial cross sectional antral area of stomach is calculated with ultrasound at pre, after 5 min, 10 min, 15 min, 20 min, 25 min and 30 min.
Interventions/Control_2
Participants rested over 60 min. Then, postprandial cross sectional antral area of stomach is calculated with ultrasound after ingesting drink at immediately after ingesting drink, after 5 min, 10 min, 15 min, 20 min, 25 min and 30 min.
Interventions/Control_3
Participants run over 60 min at 70% of maximum oxygen uptake. Then, postprandial cross sectional antral area of stomach is calculated with ultrasound at pre, after 5 min, 10 min, 15 min, 20 min, 25 min and 30 min.
Interventions/Control_4
Participants run over 60 min at 70% of maximum oxygen uptake. Then,postprandial cross sectional antral area of stomach is calculated with ultrasound after ingesting drink at immediately after ingesting drink, after 5 min, 10 min, 15 min, 20 min, 25 min and 30 min.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy subjects giving written informed consent and being evaluated cross sectional area of pyloric region of stomach with ultrasound.
Key exclusion criteria
1) Subjects with a history of allergy or might be liable to allergy related to the study
2) Subjects who have serious historical disease, marked impairment, or treatment in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism system
3) Subjects who are ineligible due to physician's judgment
4) Subjects who participate in other clinical trials
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6774
m.miyashita@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6774
Homepage URL
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
早稲田大学/Waseda University
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 20 | 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
| 2017 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 19 | Day |
Last modified on
| 2019 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034792
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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