UMIN-CTR Clinical Trial

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

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Kanagawa Insutitute of Industrial Sciense and Technology

Institute

Department

Personal name

Organization

Kanagawa

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Linking Setouchi Innate immune Network/ Control of innate immunity TRA

Name of secondary funder(s)

Cabinet Office

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

10

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

10

Month

19

Day

Last modified on

2018

Year

04

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033793