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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016124
Receipt No. R000018726
Scientific Title Effect of Continuous Intake of Sorghum Tea on Human Health
Date of disclosure of the study information 2015/01/09
Last modified on 2015/01/06

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Basic information
Public title Effect of Continuous Intake of Sorghum Tea on Human Health
Acronym Change in BMI after Continuous Intake of Sorghum Tea
Scientific Title Effect of Continuous Intake of Sorghum Tea on Human Health
Scientific Title:Acronym Change in BMI after Continuous Intake of Sorghum Tea
Region
Japan

Condition
Condition Slight overweight
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the body mass index and serum triglyceride before and after continuous intake of sorghum tea.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Body Mass Index
Key secondary outcomes Weight
Body mass index
Percent of body fat
Systolic blood pressure
Diastolic blood pressure
Triglyceride
High density lipoprotein cholesterol
Low density lipoprotein cholesterol
Total cholesterol
AST
ALT
ALP
gamma-GTP
Plasma glucose
HbA1c(NGSP)
White blood cell count
Red blood cell count
Hemoglobin
Hematocrit
Platelet count
MCV
MCH
MCHC
Creatinine
Urinary acid

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 To drink 1000 mL of sorghum tea per day for continuous 90 days.
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 Nationality as Japan

Opening health examinations for recent two years

Serum triglyceride between 120 and 200 mg/dL at the last health examination

Comprehension of this study

Informed consent for this study

Key exclusion criteria Sever systemic diseases

Liver dysfunction, renal dysfunction, or cardiovascular diseases

Allergies to any grain

Suspected of acute or chronic infection

Intake of food or supplements which could modify metabolism of lipids

Enrollment to another trial in the recent one month

Pregnancy, breast-feeding, or potential pregnancy

Judged as inappropriate by medical doctors in the study

Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Zentaro Yamagata
Organization Graduate School Department of Interdisciplinary
Research, University of Yamanashi
Division name Department of Health Sciences, Basic Science for Clinical Medicine, Division of Medicine
Zip code
Address 1110 Shimokato, Chuo City, Yamanashi, Japan
TEL +81-(0)55-273-9566
Email zenymgt@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Yokomichi
Organization Graduate School Department of Interdisciplinary Research, University of Yamanashi
Division name Department of Health Sciences, Basic Science for Clinical Medicine, Division of Medicine
Zip code
Address 1110 Shimokato, Chuo City, Yamanashi, Japan
TEL +81-(0)55-273-9566
Homepage URL
Email hyokomichi@yamanashi.ac.jp

Sponsor
Institute Department of Health Sciences, Basic Science for Clinical Medicine, Division of Medicine, Graduate School Department of Interdisciplinary Research, University of Yamanashi
Institute
Department

Funding Source
Organization Hakubaku co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2015 Year 01 Month 09 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
Body mass index and serum triglyceride were improved after continuous 90-day intake of sorghum tea without statistical significance.
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
2013 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 28 Day
Last follow-up date
2013 Year 06 Month 14 Day
Date of closure to data entry
2013 Year 07 Month 14 Day
Date trial data considered complete
2013 Year 08 Month 31 Day
Date analysis concluded
2013 Year 11 Month 14 Day

Other
Other related information No severe adverse event reported.

Management information
Registered date
2015 Year 01 Month 05 Day
Last modified on
2015 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018726

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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