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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037404
Receipt No. R000042621
Scientific Title Effect of betaine (trimethyl glycine) from sugar beet on metabolic syndrome
Date of disclosure of the study information 2019/07/22
Last modified on 2019/07/22

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Basic information
Public title Effect of betaine (trimethyl glycine) from sugar beet on metabolic syndrome
Acronym Effect of betaine from sugar beet on metabolic syndrome
Scientific Title Effect of betaine (trimethyl glycine) from sugar beet on metabolic syndrome
Scientific Title:Acronym Effect of betaine from sugar beet on metabolic syndrome
Region
Japan

Condition
Condition lifestyle-related diseases
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Preventing effects of lifestyle-related diseases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Variation of diastolic blood pressure after 2 week intervention
Key secondary outcomes Variation of factors related glucose and lipid metabolism after 2 week intervention

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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of 2g of betaine powder, 3 times per day, 2 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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria People with waist circumference is more than 85cm, serum triglyceride is more than 150mg/dL and systolic blood pressure is more than 130mmHg
Key exclusion criteria Not applicable
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Michihiro
Middle name
Last name Fukushima
Organization Obihiro University of Agriculture and Veterinary Medicine
Division name Department of Life and Food Sciences
Zip code 0808555
Address West 2-11, Inada, Obihiro, Hokkaido
TEL 0155-49-5557
Email fukushim@obihiro.ac.jp

Public contact
Name of contact person
1st name Nana
Middle name
Last name Mikami
Organization Obihiro University of Agriculture and Veterinary Medicine
Division name Department of Life and Food Sciences
Zip code 0808555
Address West 2-11, Inada, Obihiro, Hokkaido
TEL 0155-49-5570
Homepage URL
Email nanam@obihiro.ac.jp

Sponsor
Institute Obihiro University of Agriculture and Veterinary Medicine
Institute
Department

Funding Source
Organization Not applicable
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 Obihiro University of Agriculture and Veterinary Medicine
Address West 2-11, Inada, Obihiro, Hokkaido
Tel 0155-49-5345
Email shien@obihiro.ac.jp

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
2019 Year 07 Month 22 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 15
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Now preparing for submission
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
2010 Year 11 Month 19 Day
Date of IRB
2010 Year 11 Month 19 Day
Anticipated trial start date
2011 Year 01 Month 31 Day
Last follow-up date
2011 Year 02 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 18 Day
Last modified on
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042621

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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