UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy trial of single intake of plant derived ingredient. [g2019004]
Acronym	Efficacy of plant derived ingredient [g2019004]
Scientific Title	Efficacy trial of single intake of plant derived ingredient. [g2019004]
Scientific Title:Acronym	Efficacy of plant derived ingredient [g2019004]
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 a plant derived ingredient on gastrointestinal hormone in healthy male adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postprandial GLP-1 concentration (baseline, 30, 60, 90, 105, and 120 minutes after ingestion of a test meal)
Key secondary outcomes	Postprandial concentration of glucose, insulin and GIP (baseline, 30, 60, 90, 105, and 120 minutes after ingestion of a test meal)

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	6
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Single consumption of control food > wash out (1 week) > Single consumption of test food A consumption > wash out (1 week) > Single consumption of test food B consumption
Interventions/Control_2	Single consumption of control food > wash out (1 week) > Single consumption of test food B consumption > wash out (1 week) > Single consumption of test food A consumption
Interventions/Control_3	Single consumption of test food A consumption > wash out (1 week) > Single consumption of test food B consumption > wash out (1 week) > Single consumption of Control food consumption
Interventions/Control_4	Single consumption of test food A consumption > wash out (1 week) > Single consumption of Control food consumption > wash out (1 week) > Single consumption of test food B consumption
Interventions/Control_5	Single consumption of test food B consumption > wash out (1 week) > Single consumption of test food A consumption > wash out (1 week) > Single consumption of Control food consumption
Interventions/Control_6	Single consumption of test food B consumption > wash out (1 week) > Single consumption of Control food consumption > wash out (1 week) > Single consumption of test food A consumption
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	65 years-old >
Gender	Male
Key inclusion criteria	(1) Adult aged from 30 y to 65 y (2) Fasting glucose from 95 to 125 mg/dL
Key exclusion criteria	(1) Diabetes mellitus (2) Taking medicine related diabetes mellitus (3) BMI<=30kg/m2 (4) Having history or presence of cardiovascular disease or cerebrovascular disease (5) Presence 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 (6) Having history of resection of gastrointestinal tract (7) Thyroid deficiency (8) Heavy alcohol drinker (over 30g per day) (9) Donated over 200 mL of blood within the last one month prior to the study or over 400 mL of blood within the last three months prior to the study (10) Severe anemia (Hb <=7g/dL) (11) Food allergies for test foods (12) Planned to participate in other clinical study during current study (13) Shift worker (14) Determined to be unqualified by the physician in charge or the responsible person of the study
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Shinichiro Middle name Last name Saito
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	03-5630-7456
Email	saito.shinichiro@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	03-5630-7476
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	Ueno-Asagao Clinic Ethical Review Committee
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, Japan
Tel	03-6240-1162
Email	jimukyoku@tes-h.co.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	2019 Year 08 Month 20 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	Healthy adults
Participant flow	16 participants completed and 18 subjects were incorporated into the analyses (2 participant declined due to personal reasons)
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	2019 Year 07 Month 31 Day
Date of IRB	2019 Year 08 Month 07 Day
Anticipated trial start date	2019 Year 09 Month 07 Day
Last follow-up date	2019 Year 10 Month 10 Day
Date of closure to data entry	2019 Year 10 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 01 Day
Date analysis concluded	2020 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date	2019 Year 08 Month 20 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=R000043035