UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017072
Receipt number R000019802
Scientific Title Double-Blind, Placebo-Controlled Study for the Effect of Lyophilized Herring-Roe Powder on Lipid Metabolism Improvement
Date of disclosure of the study information 2015/04/08
Last modified on 2015/04/08 11:01:58

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Basic information

Public title

Double-Blind, Placebo-Controlled Study for the Effect of Lyophilized Herring-Roe Powder on Lipid Metabolism Improvement

Acronym

The Effect of Daily Ingestion of Herring-Roe Powder on Dyslipidemia

Scientific Title

Double-Blind, Placebo-Controlled Study for the Effect of Lyophilized Herring-Roe Powder on Lipid Metabolism Improvement

Scientific Title:Acronym

The Effect of Daily Ingestion of Herring-Roe Powder on Dyslipidemia

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prove the clinical usefulness of lipid metabolism improvement by investigating effects from daily ingestion of 15g of lyophilized herring-roe powder for 8 weeks.
To evaluate its overall effectiveness by additionally examining effects of the improvement of blood glucose and sleep.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

LDL-Cho

Key secondary outcomes

T-Cho,HDL-Cho,TG,RLP-Cho,NEFA,
Adiponectin, Leptin, Fasting blood glucose, HbA1c, Body weight, BMI, Body fat rate, OSA sleep inventory,
AIS


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

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

Ingestion of herring-roe powder 15g daily for 8 weeks

Interventions/Control_2

Ingestion of placebo 15g daily for 8 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

40 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1. Subjects whose LDL-Cho is between 120mg/dl and 180mg/dl.
2. Subjects who agree to participate in the current study with a written informed consent.

Key exclusion criteria

1.Subjects who are under treatment and medication for chronic ailments (especially diseases related to cancer, liver, kidney, heart, digestive system, diabetes, dyslipidemia, hypertension, mental disorder, etc.)
2.Subjects with serious cerebrovascular, cardiac, hepatic, renal and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities
3. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4. Subjects with familial hypercholesterolemia.
5. Subjects with frequent complaints of pre- or post-menopausal symptoms
6. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data
7. Subjects with serious anemia
8. Subjects who are at risk of having allergic reactions to drugs or foods (especially fish-roe, soybean)
9. Subjects who take regularly thyroid drugs, or drugs containing EPA, statin, fibrate, ezetibime and/or steroids, etc.
Or functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols, dietary fiber, etc.) which would affect the blood lipids.
10. Heavy smokers, alcohol addicts or subjects with irregular lifestyle
11. Subjects who donate either 400ml whole blood within 12 weeks or 200ml within 4 weeks, or blood component within 2 weeks prior to this study
12. Subjects who are pregnant or expected to be pregnant, or lactating during the study
13. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial
14. Any other medical reasons judged by the principal investigator

Target sample size

32


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

Email

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

Center of Health Information Science (CHIS)

Zip code


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

IHARA & COMPANY Ltd.

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


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 04 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


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

2014 Year 04 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 29 Day

Last follow-up date

2014 Year 08 Month 17 Day

Date of closure to data entry

2014 Year 08 Month 22 Day

Date trial data considered complete

2014 Year 08 Month 29 Day

Date analysis concluded

2014 Year 11 Month 26 Day


Other

Other related information



Management information

Registered date

2015 Year 04 Month 08 Day

Last modified on

2015 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019802