UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031171 |
|---|---|
| Receipt number | 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 18:06:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sakai@med.tottori-u.ac.jp
Sponsor or person
Institute
Department of Women's & Children's Family Nursing, Faculty of Medicine, Tottori University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035593
