UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effects of 4-week ingestion of the development code GIC food
Acronym	Investigation of the effects of 4-week ingestion of the development code GIC food
Scientific Title	Investigation of the effects of 4-week ingestion of the development code GIC food
Scientific Title:Acronym	Investigation of the effects of 4-week ingestion of the development code GIC food
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of GIC (development code) food ingestion effects in healthy males with a little lower lipid and glucose metabolism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the effects of 4-week intake of GIC (development code) food on lipid and glucose metabolism, skin condition, body temperature, and so on.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	In healthy males aged 20 to 59 years with a little lower lipid and glucose metabolism, daily ingestion of three GIC (development code) food capsules in a day (two capsules after lunch, one capsule after dinner) for 4 weeks.
Interventions/Control_2	In healthy males aged 20 to 59 years with a little lower lipid and glucose metabolism, daily ingestion of three placebo food capsules in a day (two capsules after lunch, one capsule after dinner) for 4 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	59 years-old >=
Gender	Male
Key inclusion criteria	-Healthy males 1.Subjects with a little higher BMI. 2.Subjects with a little higher fasting blood glucose. 3.Subjects who have a drinking habit. 4.Subjects who have a smoking habit. 5.Subjects with chronic insufficient sleep.
Key exclusion criteria	-Subjects taking GIC (development code) analog on a daily basis. -Subjects with allergy or hypersensitivity to GIC (development code). -Subjects with systemic illness. -Subjects with a anamnesis of seizures based on nervous system disorders. -Subjects who regularly take medicine. -Subjects who has changed body weight more than +/- 3kg during 3 months before the test. -Subjects with skin diseases on their face. -Subjects undergoing beauty treatment (chemical peeling, laser treatment, etc.). -Subjects who do not agree not to change their usual cosmetics during the test period.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Junko Middle name Last name Ishikawa
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7888
Email	ishikawa.junko1@kao.com

Public contact
Name of contact person	1st name Masafumi Middle name Last name Aoki
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7522
Homepage URL
Email	aoki.masafumi@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	Human Research Ethics Committee, Kao Corporation
Address	2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel	+81-3-5630-7263
Email	morisaki.naoko@kao.com

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	花王株式会社（栃木県）

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 07 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	24
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	Terminated
Date of protocol fixation	2020 Year 01 Month 10 Day
Date of IRB	2020 Year 01 Month 10 Day
Anticipated trial start date	2020 Year 01 Month 24 Day
Last follow-up date	2020 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 21 Day
Last modified on	2020 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044726