UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy trial of single intake of plant derived ingredient. [g2018002]
Acronym	Efficacy of plant derived ingredient. [g2018002]
Scientific Title	Efficacy trial of single intake of plant derived ingredient. [g2018002]
Scientific Title:Acronym	Efficacy of plant derived ingredient. [g2018002]
Region	Japan

Condition
Condition	Adults with high normal and impaired fasting glucose (fasting plasma glucose, 100-125 mg/dl)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate effects of a plant derived ingredient on glucose metabolism in 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	Dose-response assessment based on concentration of gastrointestinal hormone(tAUC, iAUC, C-max).
Key secondary outcomes	Dose-response assessment based on concentration of insulin and glucose(tAUC, iAUC, C-max).

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	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Control food consumption > wash out (1 week) > test food A consumption > wash out (1 week) > test food B consumption > wash out (1 week) > test food C consumption
Interventions/Control_2	test food A consumption > wash out (1 week) > test food B consumption > wash out (1 week) > test food C consumption > wash out (1 week) > Control food consumption
Interventions/Control_3	test food B consumption > wash out (1 week) > test food C consumption > wash out (1 week) > Control food consumption > wash out (1 week) > test food A consumption
Interventions/Control_4	test food C consumption > wash out (1 week) > Control food consumption > wash out (1 week) > test food A consumption > wash out (1 week) > test food B consumption
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)Adult aged from 20 y to 65 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 mellitus (2)Subjects taking drug related diabetes mellitus (3)Subjects who have history or symptom of cardiovascular disease or cerebrovascular disease (4)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 (5)Subjects who have a history of resection of gastrointestinal tract (6)Subjects having thyroid deficiency (7)Heavy drinker (over 30g per day) (8)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 (9)Subjects who have severe anemia (Hb <=7g/dL) (10)Subjects who have food allergies for test foods (11)Subjects who are planned to participate in other clinical study during current study (12)Subjects who are judged to be inappropriate for the study by the medical doctor or investigator for other reason
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Masanobu Middle name Last name Hibi
Organization	Kao Corporation
Division name	Biological Science Research laboratories
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL	03-5630-7266
Email	hibi.masanobu@kao.com

Public contact
Name of contact person	1st name Aya Middle name Last name Yanagimoto
Organization	Kao Corporation
Division name	Biological Science Research laboratories
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL	03-5630-7266
Homepage URL
Email	yanagimoto.aya@kao.com

Sponsor
Institute	Kao Corporation
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	Hokubukai Utsukushigaoka Hospital Ethics Committee
Address	61-1, Shinei, Kiyota-ku, Sapporo-shi, Hokkaido
Tel	011-882-0111
Email	wakimoto@ughp-cpc.jp

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	2018 Year 04 Month 26 Day

Related information
URL releasing protocol	Unpublished due to the protocol including the intellectual property rights
Publication of results	Published

Result
URL related to results and publications	works in progress
Number of participants that the trial has enrolled	18
Results	A significant difference was observed in the primary outcome.
Results date posted	2022 Year 04 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Adults with high normal and impaired fasting glucose (fasting plasma glucose, 100-125 mg/dl)
Participant flow	16 participants completed and 16 subjects were incorporated into the analyses (2 participants were discontinued due to untraceable)
Adverse events	none
Outcome measures	gastrointestinal hormone
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 04 Month 19 Day
Date of IRB	2018 Year 04 Month 19 Day
Anticipated trial start date	2018 Year 04 Month 27 Day
Last follow-up date	2018 Year 08 Month 25 Day
Date of closure to data entry	2018 Year 08 Month 31 Day
Date trial data considered complete	2019 Year 01 Month 25 Day
Date analysis concluded	2019 Year 02 Month 18 Day

Other
Other related information

Management information
Registered date	2018 Year 04 Month 25 Day
Last modified on	2022 Year 04 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036889