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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023918
Receipt No. R000027522
Scientific Title Effects of Rhodymeniales on lifestyle-related diseases and brain function
Date of disclosure of the study information 2016/09/04
Last modified on 2016/12/05

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Basic information
Public title Effects of Rhodymeniales on lifestyle-related diseases and brain function
Acronym Effects of Rhodymeniales on lifestyle-related diseases and brain function
Scientific Title Effects of Rhodymeniales on lifestyle-related diseases and brain function
Scientific Title:Acronym Effects of Rhodymeniales on lifestyle-related diseases and brain function
Region
Japan

Condition
Condition Impaired glucose tolerance
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of Rhodymeniales on lifestyle-related diseases and brain function in Japanese participants diagnosed as impaired fasting glucose or impaired glucose tolerance.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)Fasting plasma glucose
2)The plasma glucose levels and the area under the curve for glucose during oral glucose tolerance test
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 Administration of Rhodymeniales(2g/day) for 8 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
60 years-old >
Gender Male and Female
Key inclusion criteria 1)Participants who were 20-year-old or older, and younger than 60-year-old at the time of obtaining informed consent
2)Participants diagnosed as impaired fasting glucose or impaired glucose tolerance by oral glucose tolerance test
3)Participants who can visit the medical institution according to schedule
4)Participants who are able to understand the study and willing to provide written informed consent
Key exclusion criteria 1)Participants in pregnancy, lactation and scheduled pregnancy period
2)Participants who have made a blood donation within 2 (component blood donation), 4 (200mL), or 12 (400mL) weeks
3)Participants who are attending other studies or attended other studies within past 4 weeks
4)Participants with present heart, liver, kidney or thyroid disorders
5)Participants with a history of cardiac disorder
6)Participants with diabetes
7)Participants with allergy to the study foods
8)Participants who have been felt ill by blood collection
9)Participants with heavy use of alcohol
10)Participants with heavy smoking
11)Participants with irregular eating habits
12)Participants who are taking drugs, foods for specified health use or functional foods which could affect this study
13)Participants with a history of receiving a gastrointestinal surgery
14)Participants who are deemed to be unsuitable by the investigator
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tatsuya Atsumi
Organization Hokkaido University Graduate School
Division name Division of Rheumatology, Endocrinology and Nephrology
Zip code
Address N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan.
TEL 011-706-5915
Email at3tat@med.hokudai.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Akinobu Nakamura
Organization Hokkaido University Graduate School
Division name Division of Rheumatology, Endocrinology and Nephrology
Zip code
Address N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan.
TEL 011-706-5915
Homepage URL
Email akinbo@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School
Institute
Department

Funding Source
Organization Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 04 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
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 05 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
2016 Year 09 Month 02 Day
Last modified on
2016 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027522

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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