Unique ID issued by UMIN | UMIN000028706 |
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Receipt number | R000032862 |
Scientific Title | Validation study of food containing BARLEYmax on reducing body fat: Randomized double blind placebo control studies |
Date of disclosure of the study information | 2017/08/17 |
Last modified on | 2018/08/24 18:27:41 |
Validation study of food containing BARLEYmax on reducing body fat: Randomized double blind placebo control studies
Validation study for reducing body fat by BARLEYmax
Validation study of food containing BARLEYmax on reducing body fat: Randomized double blind placebo control studies
Validation study for reducing body fat by BARLEYmax
Japan |
Not applicable
Not applicable | Adult |
Others
NO
To examine effects of BARLEYmax on reducing body fat
Efficacy
Abdominal visceral fat area, abdominal subcutaneous fat area, and abdominal total fat area, at 12weeks after intake
Body weight(BMI), abdominal circumherence, fasting blood sugar level and serum lipids(total cholesterol, LDL-cholesterol, Triglycerides), at 6 and 12weeks after intake
Measurement of intestinal flora and adiponectin(polymer), at 12weeks
Defecation frequency and stool output
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Granola containing BARLEYmax, 1 food per day for 12 weeks
Granola not containing BARLEYmax, 1 food per day for 12 weeks
30 | years-old | <= |
60 | years-old | > |
Male and Female
1.Males and females aged greater than 30 and less than 60 years old
2.Subjects who usually have 3 balanced meals a day except persons who eat fermented soybeans or granola everyday
3.Subjects with BMI greater than 23 and less than 30 kg/m^2 except persons under treatment of obesity
4.Subjects who usually drink alcohol once or twice a week at most
5.Subjets giving written informed consent
1.Subjects who takes oral medication affecting obesity, hyperlipidemia and lipid metabolism
2.Subjects who suffer a severe illness in liver, cardiovascular, respiratory, endocrine, metabolism and allergy
3.Subjects who are not able to stop to take in food or supplement affecting obesity, hyperlipidemia and lipid metabolism
4.Subjects who have under treatment or a history of drug addiction and/or alcoholism
5.Subjects who have a metal component in the abdomen
6.Subjects who have a cardiac pacemaker
7.Subjects who have food allergy
8.Subjects who were diagnosed as familial hyperlipidemia
9.Pregnant and lactating female, or who wish to get pregnant during the study period
10. Subjects who is already participating or participated within 1 month in other clinical trials, subjects planning to participate during this examination period
11.Subjects who are ineligible due to physician's judgment
50
1st name | |
Middle name | |
Last name | Yoshinori Seko |
Motoyawata Central Internal medicine Clinic
Director
3-3-3 Yawata, Ichikawa, Chiba, Japan
047-704-9922
motoyawata-cmc@wd6.so-net.ne.jp
1st name | |
Middle name | |
Last name | Eiji Yoshikawa |
KSO Corporation
Sales department
1-9-7, Shibaura, Minato-ku, Tokyo, Japan
03-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
TEIJIN LIMITED
Profit organization
NO
2017 | Year | 08 | Month | 17 | Day |
Unpublished
Completed
2017 | Year | 08 | Month | 04 | Day |
2017 | Year | 09 | Month | 07 | Day |
2017 | Year | 08 | Month | 17 | Day |
2018 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032862
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