UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033034
Receipt number 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 13:21:18

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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 or person

Institute

Hokkaido Information University

Institute

Department

Personal name



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

Value
https://center6.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