UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024976 |
|---|---|
| Receipt number | R000028741 |
| Scientific Title | Effect of Daily Oral Administration of Salmon Milt Peptides on Postprandial Blood Glucose Level: Placebo-controlled Double Blind Cross Over Clinical Trial |
| Date of disclosure of the study information | 2016/11/24 |
| Last modified on | 2017/08/31 09:07:28 |
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Basic information
Public title
Effect of Daily Oral Administration of Salmon Milt Peptides on Postprandial Blood Glucose Level: Placebo-controlled Double Blind Cross Over Clinical Trial
Acronym
Effect of Daily Oral Administration of Salmon Milt Peptides on Postprandial Blood Glucose Level
Scientific Title
Effect of Daily Oral Administration of Salmon Milt Peptides on Postprandial Blood Glucose Level: Placebo-controlled Double Blind Cross Over Clinical Trial
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 10 | Month | 20 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028741
