UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018029 |
|---|---|
| Receipt number | R000020884 |
| Scientific Title | Study of effects of food containing Fucoidan on LDL-cholesterol, Blood glucose, Triglyceride. |
| Date of disclosure of the study information | 2015/06/26 |
| Last modified on | 2016/03/09 13:24:49 |
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Basic information
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
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
Primary outcomes
LDL-cholesterol
Blood glucose
Triglyceride
Total-cholesterol
HDL-cholesterol
HbA1c
Adverse event
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
y-onaka@hokugan.co.jp
Public contact
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
y.kitahara@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
Hokugan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 26 | 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 | 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
Other related information
Management 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
