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Effect of Kurozu containing diet on health: a double-blind, randomized controlled trial with parallel group design.

Not Applicable
Conditions
Healthy adults Prevention as follow, Obesity, dyslipidemia, hypertension, arteriosclerosis, diabetes mellitus, infarction or renal failure.
Registration Number
JPRN-UMIN000017706
Lead Sponsor
Kagoshima University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
After 90 days intake of Kurozu or fake Kurozu containing diet. Waist circumference Serum TG
Secondary Outcome Measures
NameTimeMethod
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
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