Unique ID issued by UMIN | UMIN000020594 |
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Receipt number | R000023774 |
Scientific Title | Intervention study on prevention of lifestyle-related diseases by continuous coffee beverage consumption |
Date of disclosure of the study information | 2016/01/19 |
Last modified on | 2019/08/22 15:50:41 |
Intervention study on prevention of lifestyle-related diseases by continuous coffee beverage consumption
Intervention study on prevention of lifestyle-related diseases by continuous coffee beverage consumption
Intervention study on prevention of lifestyle-related diseases by continuous coffee beverage consumption
Intervention study on prevention of lifestyle-related diseases by continuous coffee beverage consumption
Japan |
Persons with obesity or with high-normal blood pressure or mild hypertension
Cardiology | Endocrinology and Metabolism | Adult |
Others
NO
To test whether consumption of coffee beverage for 12 weeks decrease visceral fat area.
Efficacy
Confirmatory
Not applicable
Changes in visceral fat area at the time participants finished drinking coffee beverage for 12 weeks
Changes in blood pressure, body weight, body mass index, abdominal circumference, AST, ALT, GGTP, Total cholesterol, HDL-cholestrerol, LDL-cholestrerol, triglyceride, fasting blood glucose, HbA1c, uric acid, glycoalbumin at the time participants finished drinking coffee beverage for 12 weeks
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Prevention
Food |
Observe changes in visceral fat area after consumption of coffee beverage for 12 weeks.
Observe changes in visceral fat area after consumption of placebo beverage for 12 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
BMI >= 25kg/m2, or persons with high-normal blood pressure or with mild hypertension.
Those who are not taking medicine
Persons with severe liver damage, kidney and heart disease, oragan damage, diabetes, food allergy or other serious diseases.
180
1st name | Tatsuya |
Middle name | |
Last name | Takeshita |
Wakayama Medical University
Department of Public Health
641-8509
811-1 Kimiidera, Wakayama city, Wakayama 641-8509, Japan
+81-73-441-0647
ttakeshi@wakayama-med.ac.jp
1st name | Tatsuya |
Middle name | |
Last name | Takeshita |
Wakayama Medical University
Department of Public Health
641-8509
811-1 Kimiidera, Wakayama city, Wakayama 641-8509, Japan
+81-73-441-0647
ttakeshi@wakayama-med.ac.jp
Wakayama Medical University, Graduate School of Health and Nursing Sciences
Kao Corporation
Profit organization
Japan
Wakayama Medical University IRB
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
+81-73-447-2300
wa-rinri@wakayama-med.ac.jp
NO
和歌山市役所、かつらぎ町役場、北出病院
2016 | Year | 01 | Month | 19 | Day |
Unpublished due to the protocol including the intellectual property rights
Unpublished
works in progress
84
There were no significant results for the primary endpoint.
2019 | Year | 08 | Month | 08 | Day |
Healthy men and women
Preliminary screening for 150 people
84 people included
84 people analyzed
No adverse effect related to the test diets reported
Metabolic parameters
Main results already published
2015 | Year | 12 | Month | 11 | Day |
2015 | Year | 09 | Month | 30 | Day |
2016 | Year | 01 | Month | 19 | Day |
2016 | Year | 05 | Month | 25 | Day |
2016 | Year | 06 | Month | 11 | Day |
2016 | Year | 06 | Month | 15 | Day |
2016 | Year | 06 | Month | 30 | Day |
(Study No.2015012)
2016 | Year | 01 | Month | 16 | Day |
2019 | Year | 08 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023774
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