UMIN-CTR Clinical Trial

Basic information
Public title	Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups.
Acronym	Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups.
Scientific Title	Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups.
Scientific Title:Acronym	Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups.
Region	Japan

Condition
Condition	Healthy adult male
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the inhibitory effect on the increase in blood glucose level of 75 g OGTT and safety when the food containing pentadecyl-containing auran oil is ingested continuously for 4 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area under the curve of blood glucose level (AUC), Area under the rising curve of blood glucose level (IAUC) Evaluate at points of 4 week of intake period.
Key secondary outcomes	Area under the curve of insulin level (AUC), Area under the rising curve of insulin level (IAUC), insulinogenic index, Fasting blood glucose level, HbA1c Evaluate at points of 4 week of intake period.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	1 grains of the test product daily oral intake for 4 weeks.
Interventions/Control_2	2 grains of the test product daily oral intake for 4 weeks.
Interventions/Control_3	4 grains of the test product daily oral intake for 4 weeks.
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	Male between 20 and 64 years of age.
Key exclusion criteria	(1) Subjects who regularly use functional foods or supplements containing omega-3 fatty acids such as DHA, EPA, and Alpha-linolenic acid. (2) Subjects who regularly use functional foods or supplements containing algae (e.g., aurantiochytrium, euglena, spirulina, greenbug, etc.) (3) Subjects who regularly use medicines, health foods, foods for specified health uses, or functional foods that may affect blood glucose metabolism. (4) Subjects who are under treatment or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, or heart disease). (5) Subjects who have a disease under treatment, or a serious or pre-existing disease that requires medication. (6) Subjects with diseases that may cause diabetes or abnormalities in glucose metabolism, and subjects with a history of such diseases (e.g., pancreatic diseases, endocrine disorders, gastrectomy) (7) Subjects having possibilities for emerging allergy related to the study. (8) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination before intake. (9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. (10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires. (11) Subjects who have donated of blood within 1 month before beginning pre-inspection. (12) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	9

Research contact person
Name of lead principal investigator	1st name Yasuko Middle name Last name Sakata
Organization	Sea Act Co., LTD
Division name	Planning & Development
Zip code	100-0005
Address	2-2-1 Marunouchi, Chiyoda-ku, Tokyo
TEL	03-6268-0040
Email	sakata-yasuko@refine-hd.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Ikeda
Organization	EP Mediate Co., Ltd.
Division name	Development Business Headquarters, TTC Center, Trial Planning Department
Zip code	162-0822
Address	Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL	090-4964-4061
Homepage URL
Email	ikeda.masahiro083@eps.co.jp

Sponsor
Institute	EP Mediate Co., Ltd.
Institute
Department

Funding Source
Organization	Sea Act Co., LTD
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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	saito.teruo876@eps.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	2021 Year 09 Month 17 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	9
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	Completed
Date of protocol fixation	2021 Year 09 Month 09 Day
Date of IRB	2021 Year 09 Month 09 Day
Anticipated trial start date	2021 Year 09 Month 21 Day
Last follow-up date	2021 Year 11 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	2021 Year 09 Month 13 Day
Last modified on	2022 Year 03 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051907