UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016122 |
|---|---|
| Receipt number | R000018702 |
| Scientific Title | Effect of Sorghum Tea Intake on Inhibiting the Increase in Serum Triglyceride |
| Date of disclosure of the study information | 2015/01/09 |
| Last modified on | 2015/01/09 01:19:20 |
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Basic information
Public title
Effect of Sorghum Tea Intake on Inhibiting the Increase in Serum Triglyceride
Acronym
Effect of Sorghum Tea on Serum Triglyceride
Scientific Title
Effect of Sorghum Tea Intake on Inhibiting the Increase in Serum Triglyceride
Scientific Title:Acronym
Effect of Sorghum Tea on Serum Triglyceride
Region
| Japan |
Condition
Condition
Moderate Hypertriglyceridemia
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the postprandial increase in serum triglyceride between sorghum tea, oolong tea added with polyphenol, and water.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Increase in serum triglyceride after meals.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of 500 mL of sorghum tea
Interventions/Control_2
Intake of 500 mL of oolong tea added with polyphenol
Interventions/Control_3
Intake of 500 mL of water
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Serum triglyceride between 120 and 200 mg/dL in the recent one year at a health examination
Abstain from alcohol drinking for 21 days
Blood sampling by a needle 5 times a day
Understanding of this study
Informed consent
Key exclusion criteria
Liver dysfunction, Renal dysfunction, cardiovascular diseases, and other systemic diseases
Allergies to foods
Acute of chronic infections
Other medication, supplements, or food which influences lipid metabolism
Blood sampling for over 200 mL in the recent 1 month
Enrollment in other clinical trials in the recent 1 month
Pregnancy, breast feeding, or potential pregnangy
Judged as inappropriate for the study by any of research medical doctors
Target sample size
20
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, 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, 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, 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
No statistically significant postprandial changes in serum triglyceride between drinking sorghum tea, oolong tea added with polyphenol, and water were observed.
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
| 2012 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 14 | Day |
Date analysis concluded
| 2012 | Year | 11 | Month | 30 | Day |
Other
Other related information
No adverse event reported.
Management information
Registered date
| 2015 | Year | 01 | Month | 05 | Day |
Last modified on
| 2015 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018702
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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