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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029619
Receipt No. R000033793
Scientific Title Study on health effects of Japanese yam propagules
Date of disclosure of the study information 2017/10/19
Last modified on 2018/04/20

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Basic information
Public title Study on health effects of Japanese yam propagules
Acronym Study on health effects of Japanese yam propagules
Scientific Title Study on health effects of Japanese yam propagules
Scientific Title:Acronym 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
1st name
Middle name
Last name ABE Keiko
Organization Kanagawa Insutitute of Industrial Sciense and Technology
Division name Group for Food Functionality Assessment
Zip code
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
1st name
Middle name
Last name SHINOZAKI Fumika
Organization Kanagawa Insutitute of Industrial Sciense and Technology
Division name Group for Food Functionality Assessment
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2017 Year 10 Month 19 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000033793

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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