UMIN-CTR Clinical Trial

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	Completed
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	2020 Year 04 Month 13 Day

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