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Name:
UMIN ID:

Recruitment status Completed
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 2021/03/18

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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 Chizuko
Middle name
Last name Maruyama
Organization Japan Women's University
Division name Graduate School of Human Science and Design
Zip code 112-8681
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 Chizuko
Middle name
Last name Maruyama
Organization Japan Women's University
Division name Graduate School of Human Science and Design
Zip code 112-8681
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 Japan Women's University
Address 2-8-1, Mejirodai, Bunkyo-ku, Tokyo
Tel 0359813428
Email maruyama@fc.jwu.ac.jp

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 N/A
Publication of results Published

Result
URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/33455975/
Number of participants that the trial has enrolled 122
Results Mean LDL-cholesterol was 125 +/- 29 mg/dL at baseline, and the JD group (n=49) showed a greater mean LDL-cholesterol decrease than the PJD group (n=49) [- 8 mg/dL in JD vs 1 mg/dL in PJD, difference, -9 mg/dL (95%CI, -17 to 0) p=0.043)], and triglyceride (p=0.023) and insulin (p=0.033) reductions were larger in the JD group than in the PJD group at 6 months.

Results date posted
2021 Year 03 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Mean age was 54 years old. Men/Women = 46/52.In total, 42 (42.9 %), 18 (18.4 %) and 27 (27.6 %) participants were taking LDL-C-lowering, TG-lowering and both types of drugs, respectively, and these percentages did not differ between the JD and PJD groups
Participant flow 122 were randomized to the JD or the PJD group and 98 patients participated in the intervention at baseline.
At the 6-month follow-up, a total of 86 participants had completed the study and the retention rate was 87.8 % for both groups.
Adverse events None
Outcome measures Body weight, BMI, Waist circumference, blood pressure, serum total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, hemoglobin A1c, malondialdehyde modified-LDL, plasma glucose, serum insulin, high sensitivity C-reactive protein, leptin, high-molecular-weight adiponectin, high sensitivity tumor necrosis factor alpha, monocyte chemotactic protein-1, and interleukin-6.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 08 Day
Date of IRB
2016 Year 06 Month 28 Day
Anticipated trial start date
2016 Year 07 Month 10 Day
Last follow-up date
2019 Year 03 Month 30 Day
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
2021 Year 03 Month 18 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


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