UMIN-CTR Clinical Trial

Basic information
Public title	Effects of food intake on immunity, autonomic nerves and stress
Acronym	Effects of food intake on immunity, autonomic nerves and stress
Scientific Title	Effects of food intake on immunity, autonomic nerves and stress
Scientific Title:Acronym	Effects of food intake on immunity, autonomic nerves and stress
Region	Japan

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

Objectives
Narrative objectives1	Verification of effects on immunity, autonomic nerves and stress
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	POMS2, autonomic nerves, saliva volume, salivary IgA, cortisol, chromogranin A, BDNF, NK cell activity, phagocytic ability of the neutrophils, lymphocyte transformation
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test food (continuous intake)
Interventions/Control_2	No intake
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy adults in their 20s to 50s (2) Subjects giving written informed consent
Key exclusion criteria	(1)Individuals having diseases that affect saliva production (2)Individuals having symptoms that affect test food ingestion (3)Individuals taking medications that may affect results (4)Individuals who may develop allergies in connection with the test (5)Individuals who have the will of pregnancy or are breast-feeding during the study period (6)Individuals deemed inappropriate by the study director to participate in the study
Target sample size	50

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 Misaki Middle name Last name Matsui
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	matsui_misaki@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	Kobayashi Medical Clinic Tokyo
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	2021 Year 09 Month 06 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	50
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	2021 Year 08 Month 06 Day
Date of IRB	2021 Year 08 Month 26 Day
Anticipated trial start date	2021 Year 09 Month 14 Day
Last follow-up date	2021 Year 10 Month 08 Day
Date of closure to data entry	2021 Year 10 Month 08 Day
Date trial data considered complete	2021 Year 10 Month 28 Day
Date analysis concluded	2021 Year 11 Month 23 Day

Other
Other related information

Management information
Registered date	2021 Year 09 Month 03 Day
Last modified on	2022 Year 03 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051798