Unique ID issued by UMIN | UMIN000017706 |
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Receipt number | R000020514 |
Scientific Title | Effect of Kurozu containing diet on health: a double-blind, randomized controlled trial with parallel group design. |
Date of disclosure of the study information | 2015/06/01 |
Last modified on | 2016/03/28 17:51:15 |
Effect of Kurozu containing diet on health: a double-blind, randomized controlled trial with parallel group design.
Health promotion effect of Kurozu
Effect of Kurozu containing diet on health: a double-blind, randomized controlled trial with parallel group design.
Health promotion effect of Kurozu
Japan |
Healthy adults
Prevention as follow,
Obesity, dyslipidemia, hypertension, arteriosclerosis, diabetes mellitus, infarction or renal failure.
Not applicable | Adult |
Others
NO
Evaluation of effect of Kurozu containing diet on health promotion including obesity, lipid metabolism, blood pressure, endothelial function, glucose metabolism, blood coagulation, thrombolysis, and renal function in Men (35-60 years old and over 85 cm waist circumference) and women (35-60 years old and over 90 cm waist circumference) by a double-blind, randomized controlled trial with parallel group design.
Efficacy
Exploratory
Not applicable
After 90 days intake of Kurozu or fake Kurozu containing diet.
Waist circumference
Serum TG
After 90 days intake of Kurozu or fake Kurozu containing diet.
LDL-cholesterol
HDL-cholesterol
Adiponectin (ratio of polymer and oligomer)
Body weight, body fat weight, %body fat, lean body mass, muscle mass
Basal metabolic rate, body mass index, total body water, quantity of bone mineral
Blood pressure
Cardio ankle vascular index
Cva-a LF/HF-MEM
Fasting blood glucose
HbA1c (NGSP)
Plasma anti oxidative power
Plasma oxidation level, TBARS
Plasma TNF-alpha
Plasma CRP
Plasma homocysteine
Serum uric acid
Plasma beta-Thromboglobulin
Plasma plasminogen activator inhibitor-1
Plasma tissue-type plasminogen activator
Plasma tissue factor pathway inhibitor
Plasma tissue factor
Plasma fibrinogen
Serum creatinine and estimated glomerular filtration rate
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 |
Placebo group (fake Kurozu containing diet)
20 ml of Fake Kurozu / day
intervention period, 90 days
Trial group (Kurozu containing diet)
20 ml of Kurozu / day
intervention period, 90 days
35 | years-old | <= |
60 | years-old | >= |
Male and Female
Subjects who do not have allergy to rice or rice koji. Subjects who tend to be obesity. Subjects who were not patients of hypertension, dyslipidemia, or diabetes mellitus. Subjects who wish to improve eating habits and keep their health. Subjects who understand the purpose of this trial and want to join this trial. Subjects who was approved by the human ethics committee of Japan Society of Nutrition and Food Science and a written informed consent was obtained from each participant.
At the start of trial
1 Waist circumference, <85cm (men) or <90cm (women)
2 Blood pressure, over 140/90 mmHg, but a doctor concludes that the subject is not hypertension when the subject's blood pressure is under 147 mmHg.
3 Patient of hypertension
4 Patient of diabetes mellitus
5 Patient of dyslipidemia
6 Subjects lack cook skill or don't
have any companions who have cook skill.
7 Subjects keep taking any supplements or medicines which affect glucose or lipid metabolism over 1 month
8 Subjects take any anti-obesity drugs or supplements.
9 Allergy to rice or rice koji.
10 Subjects keep taking over 10 ml of Kurozu or Kurozu supplements corresponding to 10 ml of Kurozu over 1 month.
11 Over 6.5% HbA1c (NGSP)
12 Over 126 mg/dl of fasting blood glucose
13 Over 150 mg/dl of triglyceride
14 Over 160 mg/dl of LDL-cholesterol
If a doctor decides that the subject is needed medical treatment unless the value is <160 mg/dl, the subject is excluded.
15 Under 40 mg/dl of HDL-cholesterol
40
1st name | |
Middle name | |
Last name | Hiroaki Kanouchi |
Kagoshima University
Joint Faculty of Veterinary Medicine
1-21-24, Korimoto, Kagoshima
099-285-8716
kanouchihiroaki@mac.com
1st name | |
Middle name | |
Last name | Hiroaki Kanouchi |
Kagoshima University
Joint Faculty of Veterinary Medicine
1-21-24, Korimoto, Kagoshima
099-285-8716
kanouchihiroaki@mac.com
Kagoshima University
Sakamoto Kurozu, Inc.
Profit organization
Japan
IMJ Kagoshima
Faculty of Pharma Science, Teikyo University
The Graduate School of Medicine, Faculty of Medicine, Osaka University
Faculty of Nursing and Nutrition, Kagoshima Immaculate Heart University
The University of Tokyo Hospital
Department of Human Nutrition, Faculty of Human Nutrition, Seitoku University
Department of Psychosomatic Medicine, Kagoshima University Graduate School
NO
身体測定・生理機能検査・一般生化学検査
鹿児島大学農学部・共同獣医学部(鹿児島県)
血液凝固関連因子定量
帝京大学薬学部(東京都)
アディポネクチン定量
大阪大学大学院医学系研究科(大阪府)
壺造り米黒酢、もしくはカラメル色素で着色した醸造酢の成分評価
坂元醸造株式会社(鹿児島県)
ランダム化
東京大学医学部附属病院(東京都)
2015 | Year | 06 | Month | 01 | Day |
Unpublished
Completed
2015 | Year | 05 | Month | 07 | Day |
2015 | Year | 06 | Month | 01 | Day |
2015 | Year | 10 | Month | 17 | Day |
2016 | Year | 03 | Month | 14 | Day |
2016 | Year | 03 | Month | 14 | Day |
2016 | Year | 03 | Month | 14 | Day |
2015 | Year | 05 | Month | 27 | Day |
2016 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020514
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