UMIN-CTR Clinical Trial

Public title

Study of effects of food containing Fucoidan on LDL-cholesterol, Blood glucose, Triglyceride.

Acronym

Study of effects of food containing Fucoidan on LDL-cholesterol, Blood glucose, Triglyceride.

Scientific Title

Study of effects of food containing Fucoidan on LDL-cholesterol, Blood glucose, Triglyceride.

Scientific Title:Acronym

Study of effects of food containing Fucoidan on LDL-cholesterol, Blood glucose, Triglyceride.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect on LDL-cholesterol, fasting blood glucose, serum Triglyceride under the consumption of fucoidan for 12 weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

LDL-cholesterol
Blood glucose
Triglyceride
Total-cholesterol
HDL-cholesterol
HbA1c
Adverse event

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of the test product for 12 weeks

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Males and females from 20 to 64 years of age
(2) Subjects falling under any of the following
1. LDL-Cholesterol level is greater or equal to 120 mg/dL
2. Fasting blood glucose level is greater or equal to 100 mg/dL
3. Serum Triglyceride level is greater or equal to 150 mg/dL

Key exclusion criteria

(1) Subjects who routinely use health food containing Fucoidan
(2) Subjects who constantly use oral medication and/or functional foods affecting body fat, serum lipid levels, lipid metabolism and/or glycometabolism
(3) Subjects who has disease requiring regular medication or receiving treatment or needing treatment
(4) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(5) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(6) Subjects with allergies to the products used in the study
(7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(8) Subjects who intend to become pregnant or lactating
(9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(11) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Yuji Onaka

Organization

Hokugan Co., Ltd.

Division name

President and Director

Zip code

Address

3-6-1, Minatomachi, Naha city Okinawa

TEL

098-862-2331

Email

y-onaka@hokugan.co.jp

Name of contact person

1st name
Middle name
Last name	Yuki Kitahara

Organization

TTC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

y.kitahara@ttc-tokyo.co.jp

Institute

TTC Co.,Ltd

Institute

Department

Personal name

Organization

Hokugan Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

06

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

06

Month

11

Day

Date of IRB

Anticipated trial start date

2015

Year

06

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

06

Month

22

Day

Last modified on

2016

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020884