Unique ID issued by UMIN | UMIN000040821 |
---|---|
Receipt number | R000046600 |
Scientific Title | The effect of continuous intake of foods containing plant extract on neutral fat, liver fat and uric acid levels. |
Date of disclosure of the study information | 2020/06/26 |
Last modified on | 2021/04/15 14:37:20 |
The effect of continuous intake of foods containing plant extract on neutral fat, liver fat and uric acid levels.
The effect of continuous intake of foods containing plant extract on neutral fat, liver fat and uric acid levels.
The effect of continuous intake of foods containing plant extract on neutral fat, liver fat and uric acid levels.
The effect of continuous intake of foods containing plant extract on neutral fat, liver fat and uric acid levels.
Japan |
Healthy adults
Adult |
Others
NO
To evaluate the improving effects and safety on neutral fat, liver fat and uric acid level by ingesting the test food for 12 weeks in healthy males and females aged from 20 to 65 years old.
Safety,Efficacy
Neutral fat
Liver-spleen ratio
Physical examination: body weight, body fat percentage, BMI, waist circumference
, gamma-GTP, creatinine, HbA1c, glucose,
Insulin, TC, HDL-C, LDL-C, uric acid
questionnaire
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Take 3 tablets of the test food (low dose) daily with water or hot water.
Take 3 tablets of the test food(high dose) daily with water or hot water.
Take 3 tablets of placebo daily with water or hot water.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. 20 to 64 years old (at the time of submission of an informed consent document).
2. Japanese male and female.
3. BMI of 23.0kg/m2 to <30.0kg/m2
4. Neutral fat of <200mg/dL
5. Smartphone or PC users (who can input their own data into the electronic diary).
6. Those who do not plan to change their daily habits during the examination period.
7. Those who can provide their written informed consent.
1. Those who are currently receiving any types of medicines and/or Chinese medical treatment (except for the medication needed).
2. Those who have or had a severe disease of the liver, kidney, heart, respiratory, endocrine and metabolic diseases.
3. Those who are treated for the dyslipidemia or hyperuricemia.
4. Those who have undergone gastrointestinal surgery (appendicitis acceptable).
5. Those who have been routinely taking foods for specified health use, health foods with functional claims or supplements, which are expected to improve body fat reduction or lipid metabolism-related test values and uric acid levels.
6. Those who cannot abstain from taking health food other than test food during the test period.
7. Those who have a current or previous history of drug and/or food allergies.
8. Heavy drinkers.
9. Those who have metals implanted in the body due to surgery etc.
10. Those who have a cardiac pacemaker or an implantable medical device placed in the body.
11. Those who have claustrophobia.
12. Those who work night shifts.
13. Those who are currently undergoing treatment for drug dependence or drug abuse or those who have a past medical history of either of htem.
14. Those who have collected or donated more than 200mL within 1 month or 400mL within 3 months of the pre-examination.
15. Those who are surrently pregnant or breastfeeding or those who want to become pregnant during the study period.
16. Those who are currently participating in another clinical trial or those who took a test product and completed another clinical trial in a month.
17. Those who were determined by the principal investigator and the sub investigator to be unsuitable for participation in this clinical trial.
60
1st name | Hiroyasu |
Middle name | |
Last name | Sugimoto |
HOSODA SHC Co., Ltd.
Health care Dept.
910-0854
3-2-21 Miyuki, Fukui City, Fukui
0776-22-4748
h-sugimoto@hosoda-shc.co.jp
1st name | Hirokuni |
Middle name | |
Last name | Kayama |
IMEQRD Co., Ltd
Sales department
104-0061
6-2-1 Ginza Chuo-ku Tokyo Japan
03-6704-5968
n-yuzawa@imeqrd.co.jp
IMEQRD Co., Ltd
HOSODA SHC Co., Ltd.
Self funding
Suda Clinic institutional review board
2-8-14,Takadanobaba,Shinjyuku,Tokyo
03-6704-5968
n-yuzawa@imeqrd.co.jp
NO
2020 | Year | 06 | Month | 26 | Day |
Unpublished
60
Completed
2020 | Year | 05 | Month | 28 | Day |
2020 | Year | 05 | Month | 29 | Day |
2020 | Year | 08 | Month | 15 | Day |
2021 | Year | 01 | Month | 16 | Day |
2020 | Year | 06 | Month | 18 | Day |
2021 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046600
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |