UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039217 |
|---|---|
| Receipt number | R000044726 |
| Scientific Title | Investigation of the effects of 4-week ingestion of the development code GIC food |
| Date of disclosure of the study information | 2020/02/07 |
| Last modified on | 2020/06/29 15:41:21 |
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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
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
aoki.masafumi@kao.com
Sponsor or person
Institute
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044726
