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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031171
Receipt No. R000035593
Scientific Title Effect of seaweed-derived fucoidan on the glucose metabolism in patients with type 2 diabetes
Date of disclosure of the study information 2018/02/06
Last modified on 2018/02/06

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Basic information
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
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
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

Public contact
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

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)

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 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

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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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