UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022955
Receipt No. R000026461
Scientific Title A randomized clinical trial to assess the effect of Japan Diet intake on serum lipid and chronic inflammation parameters -a study on patients with hyperlipidemia-
Date of disclosure of the study information 2016/07/20
Last modified on 2019/01/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A randomized clinical trial to assess the effect of Japan Diet intake on serum lipid and chronic inflammation parameters -a study on patients with hyperlipidemia-
Acronym A randomized clinical trial to assess the effect of Japan Diet intake on serum lipid and chronic inflammation parameters
Scientific Title A randomized clinical trial to assess the effect of Japan Diet intake on serum lipid and chronic inflammation parameters -a study on patients with hyperlipidemia-
Scientific Title:Acronym A randomized clinical trial to assess the effect of Japan Diet intake on serum lipid and chronic inflammation parameters
Region
Japan

Condition
Condition hyperlipidemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the anti-atherosclerotic effects of Japan Diet intake, the influence of the Japan Diet intake on serum lipid levels and chronic inflammation markers are assessed in patients with hyperlipidemia.
Basic objectives2 Others
Basic objectives -Others Changes of habitual food consumption frequency comprising the Japan Diet are assessed on the Japan Diet group compared with the control group
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Following is compared between the Japan Diet group and the control diet group: Differences of changes on serum LDL-cholesterol and malondialdehyde modified (MDA)-LDL concentrations between baseline, at the end of the three-month intervention and three months after the end of the intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The control group patients attend a one-hour educational counseling concerning effective food intake to decrease to their ideal body weight. They are then encouraged to keep a daily record of their body weight and performance in terms of the intakes of recommended foods for 3 months. The records have to be e-mailed to a dietitian every month, and then each patient will receive supportive individual advice by e-mail.
Interventions/Control_2 The Japan Diet group patients are given additional information, which recommends easy ways to consume the foods classified as constituting the Japan Diet. They are then encouraged to keep a daily record of their body weight and performance in terms of the intakes of recommended foods for 3 months. The records have to be e-mailed to a dietitian every month, and then each patient will receive supportive individual advice by e-mail.
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
30 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Japanese,
BMI>22,
Fasting serum LDL-cholesterol > 140 mg/dL and/or triglyceride >150mg/dL,
Therapy: only lifestyle change or medication with the same medicine over 6 months.
Key exclusion criteria Smoker,
Habitual supplement user or health food user,Pregnant,
Familial hypercholesterolemia (homozygous),
Past history of arteriosclerosis,
eGFR < 60,
HbA1c > 8 %,
Hypothyroidism
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chizuko Maruyama
Organization Japan Women's University
Division name Graduate School of Human Science and Design
Zip code
Address 2-8-1, Mejiro-dai, Bunkyo-ku, Tokyo, Japan
TEL 81-3-5981-3428
Email maruyama@fc.jwu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chizuko Maruyama
Organization Japan Women's University
Division name Graduate School of Human Science and Design
Zip code
Address 2-8-1, Mejiro-dai, Bunkyo-ku, Tokyo, Japan
TEL 81-3-5981-3428
Homepage URL
Email maruyama@fc.jwu.ac.jp

Sponsor
Institute Japan Women's University
Institute
Department

Funding Source
Organization Japan Women's University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 20 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 No longer recruiting
Date of protocol fixation
2016 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 30 Day
Last modified on
2019 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026461

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.