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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036537
Receipt No. R000041624
Scientific Title The effects of different temperature of drink after exercise on gastric motility and energy intake
Date of disclosure of the study information 2019/04/17
Last modified on 2019/06/22

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Basic information
Public title The effects of temperature of drink after exercise on gastric motility and appetite
Acronym The effect of temperature of drink on appetite
Scientific Title The effects of different temperature of drink after exercise on gastric motility and energy intake
Scientific Title:Acronym The effects of temperature of drink 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 different temperature of drink after exercise on gastric motility and energy intake
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Energy intake
Key secondary outcomes 1) Postprandial cross-sectional antral area of stomach
2) Appetite regulating hormones
3) Blood parameters
4) 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 Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Participants run over 30 min at 80% HRmax and rest over 30 min. The 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 run over 30 min 80% HRmax and rest over 30 min. Participants then consume cold drink. The 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_3 Participants run over 30 min 80% HRmax and rest over 30 min. Participants then consume chot drink. The 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
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 Masashi
Middle name
Last name Miyashita
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
Address 2-579-15 Mikajima, Tokorozawa, Saitama
TEL 0429-47-6774
Email m.miyashita@waseda.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Miyashita
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
Address 2-579-15 Mikajima, Tokorozawa, Saitama
TEL 0429-47-6774
Homepage URL
Email m.miyashita@waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
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 Waseda University
Address 1-104, Totsuka-cho, shinjuku-ku, Tokyo
Tel 03-5272-1639
Email rinri@list.waseda.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
2019 Year 04 Month 17 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 Open public recruiting
Date of protocol fixation
2019 Year 02 Month 15 Day
Date of IRB
2019 Year 04 Month 15 Day
Anticipated trial start date
2019 Year 04 Month 24 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 17 Day
Last modified on
2019 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041624

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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