UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on health effects of Japanese yam propagules
Title of the study (Brief title)	Study on health effects of Japanese yam propagules
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to evaluate the effects of a 14-day ingestion of Jananese yam propagules on biochemical examination of blood, blood RNA, and fecal microflora in a randomized placebo-controlled crossover trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Liver function (ALT, AST, gamma-GT, ALP, LD, T-Bil)
Key secondary outcomes	Blood RNA analysis, Fecal (intestinal) mocroflora analysis, Multimodal homeostasis evaluation systems

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test food (1 cake (20g)/day) for 14 days > 14-day washout period > control food (1 cake (20g)/day) for 14 days for 14 days
Interventions/Control_2	Control food (1 cake (20g)/day) for 14 days > 14-day washout period > test food (1 cake (20g)/day) for 14 days for 14 days
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Volunteers being able to make self-judgent to particupate in this study and giving written informed consent. Healthy volunteers 20 years of age or older at the time of obtaining consent whose blood test values at the time of screening are in range shown in the point. ALT(U/L):30-50, AST(U/L):-50, gamma-GT(U/L):-100, ALP(U/L):-499, LD(U/L):-280, T-Bil(mg/dL):-2.9, RBC(10^4/microL):male 400-599, female 360-549, Hb(g/dL):male 13.1-17.9, female 12.1-15.9, Ht(%):male 38.5-50.9, female 35.5-47.9, Cre(mg/dL):male -1.09, female -0.79, T-cho(mg/dL):140-219, TG(mg/dL): 30-199, LDL-Cho(mg/dL): 60-133, HDL-Cho(mg/dL): 40-119, FPG(mg/dL):-109, HbA1c(%): -5.9
Key exclusion criteria	Volunteers whose blood test values (FPG, Hb1Ac, T-cho, TG, LDL-cho, HDL-cho, CRE, RBC, Hb, Ht) at the time of screening are in decision criteria C(follow-up), D1(requires further testing) or D2(requires treatment) of Japan Society of Ningen Dock. Volunteers whose blood test values (ALT, AST,gamma-GT, ALP, LD, T-Bil) at the time of screening are in decision criteria D1(requires further testing) or D2(requires treatment) of Japan Society of Ningen Dock. Patients with dyslipidemia or with diabetes under medical treatment or on the use of medicine. Volunteers with a risk of causing drug or food (especially yam and wheat) allergic symptoms. Volunteers taking drugs and supplements which affect the study. Volunteers who participate in other clinical trials within the last one month prior to the current clinical trial. Volunteers have donated blood more than 400mL within the last three months or more than 200mL within the last one month before the date of consent. Volunteers with any other medical reasons judged to be inappropriate by chief investigater.
Target sample size	24

Research contact person
Name of lead principal investigator	ABE Keiko
Organization	Kanagawa Insutitute of Industrial Sciense and Technology
Division name	Group for Food Functionality Assessment
Address	LiSE 4F C-4 3-25-13 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa
TEL	044-280-2187
Email	aka7308@mail.ecc.u-tokyo.ac.jp

Public contact
Name of contact person	SHINOZAKI Fumika
Organization	Kanagawa Insutitute of Industrial Sciense and Technology
Division name	Group for Food Functionality Assessment
Address	LiSE 4F C-4 3-25-13 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa
TEL	044-280-2187
Homepage URL
Email	fp-shinozaki@newkast.or.jp

Sponsor
Institute	Kanagawa Insutitute of Industrial Sciense and Technology
Institute
Department

Funding Source
Organization	Kanagawa
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor	Linking Setouchi Innate immune Network/ Control of innate immunity TRA
Name of secondary funｄer(s)	Cabinet Office

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 10 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 19 Day
Anticipated trial start date	2017 Year 10 Month 20 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	2017 Year 10 Month 19 Day
Last modified on	2018 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033793