UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000022955
Receipt number	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	2022/01/08 17:26:28

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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

hyperlipidemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

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

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 or person

Institute

Japan Women's University

Institute

Department

Personal name

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

03-5981-3274

Email

n-shien@atlas.jwu.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

2022 Year 01 Month 08 Day

Link to view the page

Value
https://center6.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