UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016124 |
|---|---|
| Receipt number | 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 08:26:14 |
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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
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
hyokomichi@yamanashi.ac.jp
Sponsor or person
Institute
Department of Health Sciences, Basic Science for Clinical Medicine, Division of Medicine, Graduate School Department of Interdisciplinary Research, University of Yamanashi
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018726
