UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical effect of intake of yogurt on body condition in summer
Title of the study (Brief title)	Yogurt intervention study
Region	Japan

Condition
Condition	N/A(healthy subjects)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the improvement effects of intake of yogurt on stress or body condition in summer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire about stress and body condition
Key secondary outcomes	Biomarker about stress and body condition

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Yogurt (once a day for 12 weeks)
Interventions/Control_2	non treatment
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	21 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Subjects giving written informed consent 2)Healthy Japanese over 21 years of age 3)Workers over three days and 40 hours per week 4)Subjects who have a BMI < 35 kg/m2
Key exclusion criteria	1)Subjects who administer medications or go to hospital regularly 2)Subjects who have a history of serious disease 3)Subjects with a compromised immune system 4)Subjects who have a history of malignancy 5)Subjects who habitually consume yogurt or fermented milk products more than three times a week within two weeks of prior to participate this study 6)Subjects have a history of allergy to food or medicine 7)Subjects who are pregnant or expected to be pregnant, or lactating during the study 8)Subjects who participate in clinical trials within the last one month prior to this study, or intend to participate in other clinical trials after consent of this study 9)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	120

Research contact person
Name of lead principal investigator	Munenori Fukui
Organization	Meiji Co., Ltd
Division name	Research & Development
Address	540 Naruda, Odawara, Kanagawa, 250-0862, Japan
TEL	0465-37-3661
Email	munenori.fukui@meiji.com

Public contact
Name of contact person	Kazuo Dairiki
Organization	Meiji Co.,Ltd
Division name	Research & Development
Address	540 Naruda, Odawara, Kanagawa, 250-0862, Japan
TEL	0465-37-3661
Homepage URL
Email	kazuo.dairiki@meiji.com

Sponsor
Institute	Meiji Co., Ltd
Institute
Department

Funding Source
Organization	Meiji Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 09 Day
Anticipated trial start date	2016 Year 07 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 07 Month 13 Day
Last modified on	2017 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026638