UMIN-CTR Clinical Trial

Public title

Effect of seaweed-derived fucoidan on the glucose metabolism in patients with type 2 diabetes

Acronym

Effect of fucoidan on T2D

Scientific Title

Effect of seaweed-derived fucoidan on the glucose metabolism in patients with type 2 diabetes

Scientific Title:Acronym

Effect of fucoidan on T2D

Region

Japan

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Fucoidan is derived from a seaweed widely used in Japanese cuisine, but little is known about its influence on glucose metabolism. To assess the physiological effects of fucoidan on glucose metabolism and on the digestive/gustatory systems, we conducted a randomized, double-blind, placebo-controlled study in patients with type 2 diabetes.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

HbA1c and fasting plasma glucose before and after 12w interventions

Key secondary outcomes

Food intake by questionnaire, bowel movements and stool characteristics, and taste thresholds of 5 basic tastes (sweetness, saltiness, sourness, bitterness, and umami)

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

fucoidan 12w -> washout 4w -> placebo 12w
1)a randomized, double-blind, placebo-controlled, cross-over study.
The subjects received numbers in the order of giving informed consent, and subjects with odd numbers were assigned to Group 1 while those with even numbers were assigned to Group 2. Group 1 ingested fucoidan for the first intervention, followed by placebo for the second intervention, while the order was reversed in Group 2. The first intervention involved daily intake of fucoidan or placebo for 12 weeks and was followed by a 4-week washout period, after which the study treatments were switched for the second 12-week intervention period.
2)Study treatments (fucoidan and placebo)
a)Fucoidan
The fucoidan beverage used as the study drug contained 810 mg (dry weight) of high molecular weight fucoidan per 30 mL. One dose of this beverage (30 mL) was taken before breakfast and dinner (60 mL/day). The safety of fucoidan was previously confirmed up to 4,050 mg/day in an overdose study conducted by Abe et al..
b) Placebo
The placebo beverage (30 mL twice daily= 60 mL/day) contained purified water and starch for viscosity. Its color was adjusted with synthetic colorant until the appearance was identical to the active beverage. Because fucoidan does not have any taste or smell, taste was not adjusted.

Interventions/Control_2

placebo 12w -> washout 4w -> fucoidan 12w
1)a randomized, double-blind, placebo-controlled, cross-over study.
The subjects received numbers in the order of giving informed consent, and subjects with odd numbers were assigned to Group 1 while those with even numbers were assigned to Group 2. Group 1 ingested fucoidan for the first intervention, followed by placebo for the second intervention, while the order was reversed in Group 2. The first intervention involved daily intake of fucoidan or placebo for 12 weeks and was followed by a 4-week washout period, after which the study treatments were switched for the second 12-week intervention period.
2)Study treatments (fucoidan and placebo)
a)Fucoidan
The fucoidan beverage used as the study drug contained 810 mg (dry weight) of high molecular weight fucoidan per 30 mL. One dose of this beverage (30 mL) was taken before breakfast and dinner (60 mL/day). The safety of fucoidan was previously confirmed up to 4,050 mg/day in an overdose study conducted by Abe et al..
b) Placebo
The placebo beverage (30 mL twice daily= 60 mL/day) contained purified water and starch for viscosity. Its color was adjusted with synthetic colorant until the appearance was identical to the active beverage. Because fucoidan does not have any taste or smell, taste was not adjusted.

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

25

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients with type 2 diabetes attending the outpatient clinic of Hakuai Hospital, Japan who were on diet therapy only and who gave consent to the test.

Key exclusion criteria

none

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Keiichi Hanaki

Organization

School of Health Sciences, Faculty of Medicine, Tottori University

Division name

Department of Women's & Children's Family Nursing

Zip code

Address

86 Nishi-cho, Yonago 683-8503, Japan

TEL

0859-38-6322

Email

hanaki-k@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Chieko Sakai

Organization

School of Health Sciences, Faculty of Medicine, Tottori University

Division name

Department of Adult and Eldery Nursing

Zip code

Address

86 Nishi-cho, Yonago 683-8503, Japan

TEL

0859-38-6317

Homepage URL

Email

sakai@med.tottori-u.ac.jp

Institute

Department of Women's & Children's Family Nursing, Faculty of Medicine, Tottori University

Institute

Department

Personal name

Organization

JSPS Grant-in-Aid

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

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

鳥取大学医学部附属病院

Date of disclosure of the study information

2018

Year

02

Month

06

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

01

Month

15

Day

Date of IRB

Anticipated trial start date

2015

Year

02

Month

15

Day

Last follow-up date

2015

Year

10

Month

29

Day

Date of closure to data entry

2016

Year

01

Month

15

Day

Date trial data considered complete

2016

Year

06

Month

01

Day

Date analysis concluded

2017

Year

12

Month

20

Day

Other related information

Registered date

2018

Year

02

Month

06

Day

Last modified on

2018

Year

02

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035593