UMIN-CTR Clinical Trial

Public title

ASAHI RIZAP Low-carbohydrate diet Study

Acronym

ASAHI RIZAP STUDY

Scientific Title

ASAHI RIZAP Low-carbohydrate diet Study

Scientific Title:Acronym

ASAHI RIZAP STUDY

Region

Japan

Condition

Type2 Diabetes mellitus
Dyslipidemia
Hypertension

Classification by specialty

Endocrinology and Metabolism

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to assess the influence of low-carbohydrate(LCD 50g or 120g) diet for patients with diabetes,dyslipidemia and hypertension.

Basic objectives2

Others

Basic objectives -Others

To evaluate the differences between LCD 50g and LCD 120g.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Every month after intervention,body weight,blood pressure,body composition will be assessed.
2,3 month after intervention,HbA1c,FPG,serum keton body,kidney and liver function and lipid profile will be checked.
C-peptide,urinary albumin,PWV/ABI will be checked at last visit.

Key secondary outcomes

To evaluate the differences between LCD 50g and LCD 120g by assessing parameters.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

[Low-carbohydrate(LCD50g)group]
Total calorie is designed according to ideal BMI and indivisual activity,and kept until study ends.

0-8w(LCD 50g period):Carbohydrate is restricted and participants are provided food contains 50g of carbohydrates per day.

8-12w(LCD 120g period):Carbohydrate is still restricted, every meal is participants'choice(no food offer),keeping 120g of carbohydrates per day.

well trained dietitians check food content everyday.

Interventions/Control_2

[Low-carbohydrate(LCD120g)group]

Total calorie is designed according to ideal BMI and indivisual activity,and kept until study ends.

0-8w(LCD 120g period):Carbohydrate is restricted and participants are provided food contains 120g of carbohydrates per day.

8-12w(LCD 120g period):Carbohydrate is still restricted, every meal is participants' choice(no food offer),keeping 120g of carbohydrates per day.

well trained dietitians check food content everyday.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

a)25<=BMI<35
b)Patients with Type2 diabetes,dyslipidemia,or hypertension.
c)HbA1c<=8.5%
d)Patients receiving certain diet and exercise therapy continuously from at least 4 weeks prior to the start of intervention.
e)Patients not taking medications in period from at least 4 weeks prior to the start of intervention,or taking same-dose medications continuously from at least 4 weeks prior to the start of intervention.
f)Patients who have been explained details of the study,understood them,and given written informed consent for participation.

Key exclusion criteria

a)Patients taking SGLT2 inhibitor
b)Patients who have severe food allergy
c)Pregnant woman,breast-feeding women and expectants.
d)Patients with diabetic nephropathy of stage3,4,5.
e)Patients with serious hepatic dysfunction.
f)Patients with serious hepatic diseases such as hepatitis.
g)sBP>=150mmHg or dBP>=100mmHg
h)Patients with history of cerebral or cardiovascular events such as cerebral infarction or miocardial infarction or severe congestive heart failure within 90 days prior to the start of intervention.
i)Patients with unstable diabetic retinopathy.
j)Patients with malignant tumors (those who are currently receiving no treatment and had no recurrense, and those considered unlikely to have any recurrense during the study period are eligible for the study)
k)Patients with severe mental disorders.
l)Patients deemed unsuitable for participation in the study by the investigator due to other reasons.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	TAKAKO KIKUCHI

Organization

The Institute for Adult Diseases,Asahi Life Foundation

Division name

chief director

Zip code

Address

Sunaga Bldg.2-2-6 Nihonbashi Bakurocho,Chuo-ku,Tokyo

TEL

03-3639-5501

Email

kikuchi-tk@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	CHIEKO KASHIWADO

Organization

Rizap

Division name

Medical Division

Zip code

Address

Shinjuku Front Tower 31F,2-21-1 Kitashinjuku,Shinjuk-ku,Tokyo

TEL

03-5389-8070

Homepage URL

Email

chieko.kashiwado@rizapgroup.com

Institute

The Institute for Adult Diseases,Asahi Life Foundation

Institute

Department

Personal name

Organization

Rizap

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

07

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2017

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2017

Year

07

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

07

Month

07

Day

Last modified on

2017

Year

07

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032191