UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Immunomodulatory effect by dietary intake of Flamulina veltipes (Enokitake)
Title of the study (Brief title)	Immunomodulatory effect by dietary intake of Flamulina veltipes (Enokitake)
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We would consider how change our immune related index and lipid related index before and after we consumed Enokitake and other mushrooms as "Foods".
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in salivary secretory IgA levels before and after mushroom ingestion for 1 week.
Key secondary outcomes	Interleukin-4 (IL-4), interleukin-6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-alpha), peripheral blood general test, neutral fat (TG), total cholesterol (TC), HDL, LDL, VLDL, blood fatty acid composition

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Test food(Enokitake 100g/day,White button mushroom 100g/day,Non-mushroom),1 week
Interventions/Control_2	Test food(Enokitake 100g/day,White button mushroom 100g/day,Non-mushroom),1 week
Interventions/Control_3	Test food(Enokitake 100g/day,White button mushroom 100g/day,Non-mushroom),1 week
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	18 years-old <=
Age-upper limit	25 years-old >=
Gender	Female
Key inclusion criteria	BMI:18.5-25.0 Physical Activity Level1,2
Key exclusion criteria	1)Invalid person 2)Smoker 3)Person who medicate by immunosuppressant or drug that may affect salivary secretion 4)Person who exercise hard daily 5)Pregnancy, nurse and these preparation 6)Systolic blood pressure under 90mmHg
Target sample size	15

Research contact person
Name of lead principal investigator	Kawabata Terue
Organization	Kagawa Nutrition Univercity
Division name	Basic Nutrition Laboratory
Address	3-9-21 Chiyoda Sakado-city Saitama Japan
TEL	049-282-3705
Email	enoki-kiso@eiyo.ac.jp

Public contact
Name of contact person	Hara Yukiko
Organization	Kagawa Nutrition Univercity
Division name	Basic Nutrition Laboratory
Address	3-9-21 Chiyoda Sakado-city Saitama Japan
TEL	049-282-3705
Homepage URL
Email	hya171@eiyo.ac.jp

Sponsor
Institute	Kagawa Nutrition Univercity
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 07 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 05 Month 23 Day
Anticipated trial start date	2018 Year 06 Month 05 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	2018 Year 06 Month 21 Day
Last modified on	2018 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037603