UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018339
Receipt number R000021227
Scientific Title Investigation of the effects of supplementation with curcuminoids in subjects with metabolic syndrome
Date of disclosure of the study information 2015/07/17
Last modified on 2015/07/17 22:54:52

* 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

Investigation of the effects of supplementation with curcuminoids in subjects with metabolic syndrome

Acronym

Curcuminoid supplementation in metabolic syndrome

Scientific Title

Investigation of the effects of supplementation with curcuminoids in subjects with metabolic syndrome

Scientific Title:Acronym

Curcuminoid supplementation in metabolic syndrome

Region

Asia(except Japan)


Condition

Condition

Metabolic syndrome

Classification by specialty

Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of curcuminoids' effects on serum lipid concentrations

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Changes in serum levels of total cholesterol, LDL- cholesterol, HDL-cholesterol, triglycerides, lipoprotein(a), small-dense LDL and non-HDL-cholesterol

Key secondary outcomes

Changes in serum levels of adiponectin, leptin, C-reactive protein, malondialdehyde, superoxide dismutase, tumor necrosis factor-alpha, transforming growth factor-beta, interleukin-6 and monocyte chemoattractant protein-1


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Curcuminoids (1000 mg/day)

Interventions/Control_2

Placebo

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

25 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Diagnosis of metabolic syndrome based on the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guidelines a follows: >= 3 of the following conditions: waist circumference >= 102 cm (male) or >= 88 cm (female), blood pressure >= 130/85 mmHg, triglycerides >= 1.7 mmol/L, HDL-C < 1.03 mmol/L (males) or < 1.29 mmol/L (females), fasting plasma glucose (FPG) >= 6.1 mmol/L.

Key exclusion criteria

Pregnancy and breastfeeding, non-compliance with the study medication (defined as not using the medication for > 1 week), participation in a concomitant trial, hypersensitivity to the study medication, presence of malignancies and Impossibility to give informed consent.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Amirhossein Sahebkar

Organization

Mashhad University of Medical Sciences, Mashhad, Iran

Division name

Biotechnology Research Center

Zip code


Address

Vakilabad blvd. Mashhad 9177948564, Iran

TEL

+989151221496

Email

amir_saheb2000@yahoo.com


Public contact

Name of contact person

1st name
Middle name
Last name Amirhossein Sahebkar

Organization

Mashhad University of Medical Sciences, Mashhad, Iran

Division name

Biotechnology Research Center

Zip code


Address

Vakilabad blvd. Mashhad 9177948564, Iran

TEL

+989151221496

Homepage URL


Email

amir_saheb2000@yahoo.com


Sponsor or person

Institute

Clinical Trial Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran

Institute

Department

Personal name



Funding Source

Organization

Clinical Trial Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Clinical Trial Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran


Other related organizations

Co-sponsor

Mashhad University of Medical Sciences, Mashhad, Iran

Name of secondary funder(s)

Mashhad University of Medical Sciences, Mashhad, Iran


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

Endocrinology Clinic, Baqiyatallah Hospital, Tehran, Iran

Cardiology Clinic, Baqiyatallah Hospital, Tehran, Iran


Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 17 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

Significant reductions in palsma concentrations of total cholesterol, LDL-cholesterol, triglycerides,non-HDL-choletserol and lipoprotein(a), and elevations in HDL-cholesterol following 8-week supplementation with curcuminoids.

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

2013 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 01 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

2015 Year 07 Month 17 Day

Last modified on

2015 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021227


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name