UMIN-CTR Clinical Trial

Basic information
Public title	The effects and value food intake on energy consumption
Acronym	The effects and value food intake on energy consumption
Scientific Title	The effects and value food intake on energy consumption
Scientific Title:Acronym	The effects and value food intake on energy consumption
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects and value food intake on energy consumption
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of energy consumption between the test and control groups
Key secondary outcomes	Comparison of energy consumption between the test and standing position or walking Fat consumption Carbohydrate consumption Height Body weight Muscle mass

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	4
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Test food
Interventions/Control_2	Control food
Interventions/Control_3	Comparison
Interventions/Control_4	Reference Comparison
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Healthy person over 20 years of age (2)A person who can refrain from strenuous exercise and drinking the day before the test date (3)A person who have eaten gum before and can take it in with no problem
Key exclusion criteria	(1)Pregnat,lactating (2)A person who take metabolic treatments,medications or supplements (3)A person who have food allergies
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Osawa
Organization	Lotte Co., Ltd
Division name	Central Laboratory, Kamukoto Research Department
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0744
Email	Oosawa_Kenji@lotte.co.jp

Public contact
Name of contact person	1st name Naoya Middle name Last name Ooshima
Organization	Lotte Co., Ltd.
Division name	Central Laboratory, Kamukoto Research Department
Zip code	336-8601
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0744
Homepage URL
Email	Ooshima_Naoya@lotte.co.jp

Sponsor
Institute	Lotte Co., Ltd.
Institute
Department

Funding Source
Organization	Lotte Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shiba Palace Clinic
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel	03-5408-1590
Email	jimukyoku@mail.souken-r.com

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	2020 Year 08 Month 21 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	20
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	2020 Year 08 Month 18 Day
Date of IRB	2020 Year 08 Month 17 Day
Anticipated trial start date	2020 Year 08 Month 25 Day
Last follow-up date	2020 Year 10 Month 16 Day
Date of closure to data entry	2020 Year 10 Month 16 Day
Date trial data considered complete	2020 Year 10 Month 16 Day
Date analysis concluded	2020 Year 11 Month 06 Day

Other
Other related information

Management information
Registered date	2020 Year 08 Month 21 Day
Last modified on	2021 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047377