UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of seaweed-derived fucoidan on the glucose metabolism in patients with type 2 diabetes
Title of the study (Brief title)	Effect of fucoidan on T2D
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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)

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Keiichi Hanaki
Organization	School of Health Sciences, Faculty of Medicine, Tottori University
Division name	Department of Women's & Children's Family Nursing
Address	86 Nishi-cho, Yonago 683-8503, Japan
TEL	0859-38-6322
Email	hanaki-k@umin.ac.jp

Public contact
Name of contact person	Chieko Sakai
Organization	School of Health Sciences, Faculty of Medicine, Tottori University
Division name	Department of Adult and Eldery Nursing
Address	86 Nishi-cho, Yonago 683-8503, Japan
TEL	0859-38-6317
Homepage URL
Email	sakai@med.tottori-u.ac.jp

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

Funding Source
Organization	JSPS Grant-in-Aid
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	鳥取大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 06 Day
Last modified on	2018 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035593