UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating psychological and physical effect of intake food at commuting time. A no treatment-controlled, stratified randomization, single-blind, parallel trial.
Title of the study (Brief title)	A study for evaluating psychological and physical effect of intake food at commuting time.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the influence on BMI and body fat due to continuous ingestion of test food at commuting time. And verify the effect of test food on stress that subjects feel during a single attendance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subject's body fat, before test, after 4 and 8 weeks from starting test
Key secondary outcomes	BMI, Body height, body weight, muscle mass, basal metabolic rate and abdominal girth of the subject, 4 and 8 weeks from starting test Subject's stress felt at attendance time (any day)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food at commuting (8 weeks (work day) ingestion)
Interventions/Control_2	No intake at commuting time (8 weeks (work day))
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females from 20 to 59 years of age (2) Subjects giving written informed consent
Key exclusion criteria	(1) Individuals who have symptoms that affect test food intake and walking (2) Currently, individuals are receiving treatment some diseases, especially mental health. Or individuals are using supplements or health foods for stress (3) Individuals presenting known food allergy in connection with the exam (4) Individuals who are pregnant (5) Individuals currently losing weight (6) Individuals who feel that it is difficult to keep eating test foods during commuting time (7) Individuals who think are not able to perform the test more than 80% on work day. (8) Individuals who are judged as unsuitable for the study by the investigator
Target sample size	100

Research contact person
Name of lead principal investigator	Kenji Oosawa
Organization	Lotte Co., Ltd.
Division name	Central Laboratory
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0275
Email	Oosawa_Kenji@lotte.co.jp

Public contact
Name of contact person	Susumu Kanno
Organization	Lotte Co., Ltd.
Division name	Central Laboratory
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0187
Homepage URL
Email	Kanno_susumu@lotte.co.jp

Sponsor
Institute	Lotte Co., Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2018 Year 01 Month 19 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 25 Day
Anticipated trial start date	2018 Year 01 Month 26 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 10 Day
Date trial data considered complete	2018 Year 07 Month 13 Day
Date analysis concluded	2018 Year 08 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 19 Day
Last modified on	2018 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035257