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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033034
Receipt No. R000037662
Scientific Title Effect of Daily Ingestion of the Tuna Dark Muscle Contained Color-faded Laver on visceral fat for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Date of disclosure of the study information 2018/06/18
Last modified on 2019/05/29

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Basic information
Public title Effect of Daily Ingestion of the Tuna Dark Muscle Contained Color-faded Laver on visceral fat for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym Beneficial Effects of the Tuna Dark Muscle Contained Color-faded Laver on Visceral Fat
Scientific Title Effect of Daily Ingestion of the Tuna Dark Muscle Contained Color-faded Laver on visceral fat for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym Beneficial Effects of the Tuna Dark Muscle Contained Color-faded Laver on Visceral Fat
Region
Japan

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

Objectives
Narrative objectives1 To prove the effect of the Tuna Dark Muscle Contained Color-faded Laver on visceral fat associated with 12 week daily ingestion in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Visceral fat area at 12 weeks after beginning the ingestion of test food.
Key secondary outcomes total fat area, subcutaneous fat area, fasting blood glucose, HbA1c, fasting insulin, HOMA-IR, blood glucose and insulin after OGTT, body weight, body mass index, body fat rate, muscle mass, abdominal circumference, TBARS, total selenium, selenoneine, total mercury, selenoprotein P, TMAO, VAS questionnaire assessed condition of gastrointestinal tract

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily ingestion of 82 g the tuna dark muscle hamburger steak contained color-faded laver for 12 weeks.
Interventions/Control_2 Daily ingestion of 67 g beef meat and Okara hamburger steak for 12 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
35 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1.Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2.Subjects whose BMI is >=23 kg/m2 and <30 kg/m2.
Key exclusion criteria 1.Subjects who are under physician's advice, treatment, and/or medication for obese, dyslipidemia and/or diabetes.
2.Subjects whose postprandial blood glucose is >=200 mg/dl and/or HbA1c >=6.5%.
3.Pacemaker or defibrillator users.
4.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
5.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
7.Subjects with severe anemia.
8.Pre- or post-menopausal women complaining of obvious physical changes.
9.Subjects who are at risk of having allergic reactions to drugs or foods especially based on fish, seaweed, beef, soybean, shrimp, crab, wheat, chicken, or milk.
10.Subjects who regularly take medicine, functional foods, and/or supplements which would affect BW and BFP.
11.Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid metabolism.
12.Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism.
13.Alcohol addicts or subjects with eating disordered lifestyle.
14.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
15.Pregnant or lactating women or women who expect to be pregnant during this study.
16.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
17.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name NISHIHIRA
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code 069-8585
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
1st name Jun
Middle name
Last name NISHIHIRA
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code 069-8585
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 NARO Bio-oriented Technology Research Advancement Institution
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The ethics committee of Hokkaido Information University
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel 011-385-4411
Email soumu@do-johodai.ac.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 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
2018 Year 06 Month 18 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 60
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
2018 Year 05 Month 25 Day
Date of IRB
2018 Year 05 Month 25 Day
Anticipated trial start date
2018 Year 06 Month 20 Day
Last follow-up date
2018 Year 10 Month 04 Day
Date of closure to data entry
2018 Year 12 Month 04 Day
Date trial data considered complete
2018 Year 12 Month 11 Day
Date analysis concluded
2019 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 18 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037662

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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