UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020119
Receipt number R000023139
Scientific Title The effects of components in brown algae on prevention of lifestyle-related diseases, a randomized controlled trial.
Date of disclosure of the study information 2015/12/08
Last modified on 2015/12/08 16:06:15

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Basic information

Public title

The effects of components in brown algae on prevention of lifestyle-related diseases, a randomized controlled trial.

Acronym

The effects of components in brown algae on prevention of lifestyle-related diseases.

Scientific Title

The effects of components in brown algae on prevention of lifestyle-related diseases, a randomized controlled trial.

Scientific Title:Acronym

The effects of components in brown algae on prevention of lifestyle-related diseases.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Preventing effects of life style-related diseases

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

Variation of visceral fat area after 8 week intervention

Key secondary outcomes

Variations of factors related glucose and lipid metabolism after 8 week intervention


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of capsule including 2 mg of component in brown algae
1 capsule per day, 8 weeks

Interventions/Control_2

Intake of capsule including 1 mg of component in brown algae
1 capsule per day, 8 weeks

Interventions/Control_3

Intake of capsule without component in brown algae
1 capsule per day, 8 weeks

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Adults with BMI is more than 22.

Key exclusion criteria

Some one who has allergy for seaweed.
Some one who is pregnant, breastfeeding or possibly pregnant.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Kokai

Organization

Sapporo Medical University

Division name

School of Medicine

Zip code


Address

South-1, West-17, Chuo-ku, Sapporo, Hokkaido

TEL

011-611-2111

Email

kokai@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nana Mikami

Organization

Sapporo Medical University

Division name

School of Medicine

Zip code


Address

South-1, West-17, Chuo-ku, Sapporo, Hokkaido

TEL

011-611-2111

Homepage URL


Email

mikami7@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University

Institute

Department

Personal name



Funding Source

Organization

MEXT

Organization

Division

Category of Funding 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



Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 08 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

2013 Year 11 Month 04 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 29 Day

Last follow-up date

2014 Year 03 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 08 Day

Last modified on

2015 Year 12 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023139


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name