UMIN-CTR Clinical Trial

Basic information
Public title	An examination of the factors affecting appetite regulating hormones
Acronym	Appetite and appetite regulating hormones
Scientific Title	An examination of the factors affecting appetite regulating hormones
Scientific Title:Acronym	Appetite and appetite regulating hormones
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 expansion of stomach on appetite regulating hormones
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 area of pyloric region of stomach. 2) Ghrelin, Peptide YY
Key secondary outcomes	Blood parameters, Subjective hunger by visual analog scale (VAS)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	To calculate postprandial cross sectional area of pyloric region of stomach using ultrasound after drinking a large quantity of the test drink.
Interventions/Control_2	To calculate postprandial cross sectional area of pyloric region of stomach using ultrasound after drinking a small quantity of the test drink.
Interventions/Control_3
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	30 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	12

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
Email	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
Email	m.miyashita@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Waseda University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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（埼玉県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 04 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	2016 Year 07 Month 11 Day
Date of IRB	2016 Year 07 Month 06 Day
Anticipated trial start date	2016 Year 08 Month 03 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 03 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=R000027031