UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016509
Receipt No. R000019173
Scientific Title Effect of postprandial blood glucose level by the continuity intake of salmon milt peptides in placebo-controlled double blind cross over clinical trial
Date of disclosure of the study information 2015/02/11
Last modified on 2015/08/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of postprandial blood glucose level by the continuity intake of salmon milt peptides in placebo-controlled double blind cross over clinical trial
Acronym Effect of salmon milt peptides on postprandial blood glucose level
Scientific Title Effect of postprandial blood glucose level by the continuity intake of salmon milt peptides in placebo-controlled double blind cross over clinical trial
Scientific Title:Acronym Effect of salmon milt peptides on postprandial blood glucose level
Region
Japan

Condition
Condition postprandial hyperglycemia
Classification by specialty
Endocrinology and Metabolism
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 test.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Serum glucose level
Key secondary outcomes Insulin

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 Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake 500 mg salmon milt peptides capsule for 1 week, and take wash out period for 1 week, and then, intake placebo capsule for 1 week.
Interventions/Control_2 Intake placebo capsule for 1 week, and take wash out period for 1 week, and then, intake 500mg salmon milt peptides capsule for 1 week.
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
35 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 who agree to participate in the current study with written informed consent.
Key exclusion criteria (1) Subjects who are under medication for diabetes and dyslipidemia.
(2) HbA1c>=6.6%
(3) FPG>=126mg/dl
(4) Subjects with insulin resistance (HOMA-IR>=2.5)
(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 and gelatin.
(11) Subjects routinely on supplementation which would affect glucose metabolism.
(12) Subjects routinely on supplementation which would affect lipid metabolism.
(13) Heavy smokers and alcohol addicts, or subjects with irregular lifestyle.
(14) Subjects who donate 400ml whole blood within 12 weeks or who donate plasma or platelets within 4 weeks prior to supplementation.
(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 one month prior to the current clinical trial.
(17) Subjects who are not eligible due to physician's judgment.


Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun Nishihira, M.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun Nishihira, M.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
Address 59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
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
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 02 Month 11 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
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
2015 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 24 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 04 Month 15 Day
Date trial data considered complete
2015 Year 04 Month 22 Day
Date analysis concluded
2015 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 11 Day
Last modified on
2015 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019173

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.