UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020121 |
|---|---|
| Receipt number | R000023168 |
| Scientific Title | The effects of components in brown algae on prevention of lifestyle-related diseases, a crossover trial. |
| Date of disclosure of the study information | 2015/12/08 |
| Last modified on | 2015/12/08 16:45:04 |
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Basic information
Public title
The effects of components in brown algae on prevention of lifestyle-related diseases, a crossover trial.
Acronym
The effects of components in brown algae on prevention of lifestyle-related diseases.
Scientific Title
The effects of components in brown algae on prevention of lifestyle-related diseases, a crossover trial.
Scientific Title:Acronym
The effects of components in brown algae on prevention of lifestyle-related diseases.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
prevention for diabetic conditions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
HbA1c value after 8 weeks intervention
Key secondary outcomes
Variation of factors associated with lifestyle-related diseases, basal metabolism and chronic inflammation after 8 weeks intervention
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake one capsule including 2mg of component in brown algae per day for 8 weeks, and then intake one capsule without the component per day for 8 weeks after 2 week washout period.
Interventions/Control_2
Intake one capsule without a component in brown algae per day for 8 weeks, and then intake one capsule inxcluding 2mg of the component per day for 8 weeks after 2 week washout period.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults with BMI is more than 22.
People met either of the following conditions;
(1) Fasting glucose level (more than 12h)is 110-125mg/dL.
(2) Casual glucose level is 140-200mg/dL.
(3) HbA1c value is 5.8-6.4% (NGSP).
Key exclusion criteria
Some one who has allergy for seaweed.
Some one who is pregnant, breastfeeding or possibly pregnant.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Kokai |
Organization
Sapporo Medical University
Division name
School of Medicine
Zip code
Address
South-1, West-17, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
kokai@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nana Mikami |
Organization
Sapporo Medical University
Division name
School of Medicine
Zip code
Address
South-1, West-17, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
mikami7@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding 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 | 12 | Month | 08 | 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
| 2014 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 08 | Day |
Last modified on
| 2015 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023168
