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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017706
Receipt No. 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

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Basic information
Public title Effect of Kurozu containing diet on health: a double-blind, randomized controlled trial with parallel group design.
Acronym Health promotion effect of Kurozu
Scientific Title Effect of Kurozu containing diet on health: a double-blind, randomized controlled trial with parallel group design.
Scientific Title:Acronym Health promotion effect of Kurozu
Region
Japan

Condition
Condition Healthy adults
Prevention as follow,
Obesity, dyslipidemia, hypertension, arteriosclerosis, diabetes mellitus, infarction or renal failure.
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes After 90 days intake of Kurozu or fake Kurozu containing diet.
Waist circumference
Serum TG
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Placebo group (fake Kurozu containing diet)
20 ml of Fake Kurozu / day
intervention period, 90 days
Interventions/Control_2 Trial group (Kurozu containing diet)
20 ml of Kurozu / day
intervention period, 90 days
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
35 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 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.
Key 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
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Kanouchi
Organization Kagoshima University
Division name Joint Faculty of Veterinary Medicine
Zip code
Address 1-21-24, Korimoto, Kagoshima
TEL 099-285-8716
Email kanouchihiroaki@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Kanouchi
Organization Kagoshima University
Division name Joint Faculty of Veterinary Medicine
Zip code
Address 1-21-24, Korimoto, Kagoshima
TEL 099-285-8716
Homepage URL
Email kanouchihiroaki@mac.com

Sponsor
Institute Kagoshima University
Institute
Department

Funding Source
Organization Sakamoto Kurozu, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2015 Year 10 Month 17 Day
Date of closure to data entry
2016 Year 03 Month 14 Day
Date trial data considered complete
2016 Year 03 Month 14 Day
Date analysis concluded
2016 Year 03 Month 14 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 27 Day
Last modified on
2016 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020514

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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