UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017188
Receipt number R000019939
Scientific Title The effect of lifestyle modification program on the plasma free amino acid profile in subjects with metabolic syndrome
Date of disclosure of the study information 2015/05/01
Last modified on 2015/04/20 14:12:59

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Basic information

Public title

The effect of lifestyle modification program on the plasma free amino acid profile in subjects with metabolic syndrome

Acronym

The effect of lifestyle modification program on the plasma free amino acid profile in subjects with metabolic syndrome

Scientific Title

The effect of lifestyle modification program on the plasma free amino acid profile in subjects with metabolic syndrome

Scientific Title:Acronym

The effect of lifestyle modification program on the plasma free amino acid profile in subjects with metabolic syndrome

Region

Japan


Condition

Condition

Metabolic syndrome

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of the improvement of metabolic syndrome on the plasma amino acid profile

Basic objectives2

Others

Basic objectives -Others

Relationship between plasma amino acid profiles and metabolic syndrome

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Plasma amino acid concentrations

Key secondary outcomes

Variables regarding metabolic syndrome


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Lifestyle modification program

Interventions/Control_2


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subject who signed the informed consent to participate in the study
Subject who fulfilled the diagnostic criteria of metabolic syndrome (1 or 2 below)
1. BMI >=30kg/m2
2. waist circumference >=85cm (male)/90cm (female) or BMI >=25kg/m2
and
hypertension (Systolic BP >=130mmHg or diastolic BP >=85mmHg) or Hyperglycemia (fasting blood glucose >=110mg/dL) or hyperlipidemia (triglyceride >=150mg/dL or HDL cholesterol <40mg/dL)

Key exclusion criteria

Hepatitis C patient
HIV patient

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Tochikubo

Organization

Yokohama City University

Division name

School of Medicine, Department of Public Health

Zip code


Address

3-9, Fukuura, Kanazawa-ku, Yokohama-shi

TEL

045-787-2610

Email

tocchi@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Tochikubo

Organization

Yokohama City University

Division name

School of Medicine, Department of Public Health

Zip code


Address

3-9, Fukuura, Kanazawa-ku, Yokohama-shi

TEL

045-787-2610

Homepage URL


Email

tocchi@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Ajinomoto Co., Inc.

Institute

Department

Personal name



Funding Source

Organization

Ajinomoto Co., Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

神奈川県予防医学協会(神奈川県)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

The improvement of metabolic syndrome after a lifestyle modification program was accompanied by a normalization of PFAA profiles.

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

2006 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2006 Year 07 Month 18 Day

Last follow-up date

2011 Year 03 Month 24 Day

Date of closure to data entry

2014 Year 11 Month 06 Day

Date trial data considered complete

2014 Year 11 Month 06 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 20 Day

Last modified on

2015 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019939


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name