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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034130
Receipt No. 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

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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
Institute TES Holdings Co., Ltd.
Institute
Department

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
URL(English) https://upload.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


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