UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034130
Receipt number R000038910
Scientific Title Efficacy trial of repeated intake of plant derived ingredient. [trial number g2018007]
Date of disclosure of the study information 2018/09/25
Last modified on 2018/09/14 08:44:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Efficacy trial of repeated intake of plant derived ingredient. [trial number g2018007]

Acronym

Efficacy of plant derived ingredient. [trial number g2018007]

Scientific Title

Efficacy trial of repeated intake of plant derived ingredient. [trial number g2018007]

Scientific Title:Acronym

Efficacy of plant derived ingredient. [trial number g2018007]

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate effects of repeated consumption of a plant derived ingredient for 2 weeks on glucose metabolism in healthy adults with high normal and impaired fasting glucose

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood glucose

Key secondary outcomes

Insulin, glucagon, 1.5-AG, glycol-albumin, gastrointestinal hormone, triglyceride, apo B48, ketone body, body weight, body fat ratio, appetite (questionnaire)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Repeated intake control food, once in a day for 2 weeks, after wash out for 2 weeks, repeated intake test food, once in a day for 2 weeks.

Interventions/Control_2

Repeated intake test food, once in a day for 2 weeks, after wash out for 2 weeks, repeated intake control food, once in a day for 2 weeks.

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

64 years-old >=

Gender

Male

Key inclusion criteria

(1) Healthy male adults aged from 20 y to 64 y
(2) Subjects with fasting glucose from 100 to 125 mg/dl
(3) Subjects can consume test foods, and record life diaries and meal diaries
(4) Subjects who have given written informed consent prior to study

Key exclusion criteria

(1) Subjects diagnosed with diabetes, or taking drugs related diabetes
(2) Subjects who have history or symptom of cardiovascular disease or cerebrovascular disease
(3) Subjects who have symptom of liver, kidney or respiratory disease, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, allergy disease, mental disorder, cancer, infection disease, or other diseases
(4) Subjects who have a history of resection of gastrointestinal tract, excluding cecal resection surgery
(5) Heavy drinker (over 30g alcohol per day)
(6) Subjects who have donated over 200 ml of blood within the last one month prior to the current study or over 400 ml of blood within the last three months prior to the study
(7) Subjects who have severe anemia (Hb <=7g/dL)
(8) Subjects who have food allergies for test foods
(9) Subjects who are planned to participate in other clinical study during current study
(10) Subjects who are judged to be inappropriate for the study by the medical doctor or principal investigator for other reason

Target sample size

14


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masanobu Hibi

Organization

Kao Corporation

Division name

Biological Science Research laboratories

Zip code


Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan

TEL

+81-3-5630-7266

Email

hibi.masanobu@kao.com


Public contact

Name of contact person

1st name
Middle name
Last name Ryoma Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code


Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



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

うえのあさがおクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 25 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

Preinitiation

Date of protocol fixation

2018 Year 08 Month 31 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 29 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

2018 Year 09 Month 14 Day

Last modified on

2018 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038910


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name