UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Daily Oral Administration of Salmon Milt Peptides on Postprandial Blood Glucose Level: Placebo-controlled Double Blind Cross Over Clinical Trial
Title of the study (Brief title)	Effect of Daily Oral Administration of Salmon Milt Peptides on Postprandial Blood Glucose Level
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to evaluate the effect of salmon milt peptides on the postprandial blood glucose level by double-blind, placebo-controlled cross over trial.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FBG at baseline and at 30 min, 60 min, 90 min, 120 min after oral glucose load, and AUC.
Key secondary outcomes	Fasting Insulin level at baseline and at 30 min, 60 min, 90 min, 120 min after oral glucose load, and AUC.

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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Daily intake for 2 weeks salmon milt peptides tablets, and take wash out period for 2 weeks, and then, daily intake for 2 weeks placebo tablets.
Interventions/Control_2	Daily intake for 2 weeks placebo tablets, and take wash out period for 2 weeks, and then, daily intake for 2 weeks salmon milt peptides tablets.
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	30 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Subjects with high serum glucose levels at 60 min after oral glucose load. 2. Subjects whose HOMA-IR is <1.6. 3. Subjects who agree to participate in the current study with written informed consent.
Key exclusion criteria	1.Subjects who are under treatment and medication for diabetes and dyslipidemia. 2.Subjects whose HbA1c>=6.5% 3.Subjects whose FBG>=126 mg/dl. 4.Subjects whose BFP>=40% 5.Subjects with serious disease and infection. 6.Subjects with clinical history of gastrointestinal surgery. 7.Subjects with unusually high and/or low blood pressure, or with abnormal hematological data. 8.Subjects with serious anemia. 9.Subjects with frequent complaints of post-menopausal symptoms. 10.Subjects with a history of allergy to medicine and food, especially salmon. 11.Subjects regularly take medicine, functional foods and/or supplements which would affect glucose metabolism. 12.Subjects regularly take medicine, functional foods and/or supplements which would affect lipid metabolism. 13.Subjects who are heavy smokers and alcohol addicts, or subjects with irregular lifestyle. 14.Subjects who donated either 400 ml whole blood within 12 weeks (men) /16 weeks (women) or 200 ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 15.Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study. 16.Subjects who participate in other clinical trials within the last 4 weeks prior to the current clinical trial. 17.Subjects who are not eligible due to physician's judgment.
Target sample size	18

Research contact person
Name of lead principal investigator	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4411
Email	nishihira@do-johodai.ac.jp

Public contact
Name of contact person	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Health Information Science Center
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4430
Homepage URL
Email	nishihira@do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	Maruha Nichiro Corporation, Central Research Institute
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	北海道情報大学　保健センター（北海道）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 20 Day
Anticipated trial start date	2016 Year 12 Month 16 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry	2017 Year 04 Month 05 Day
Date trial data considered complete	2017 Year 04 Month 12 Day
Date analysis concluded	2017 Year 08 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 24 Day
Last modified on	2017 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028741