The Effects of Nanomicelles Curcumin on Glycemic Control, Serum Lipid Profile ,Blood Pressure and Anthropometric Measurements in Patients With Metabolic Syndrome

NCT ID: NCT03534024

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2020-01-30

Brief Summary

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Metabolic syndrome is a condition which is recognized by abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. Curcumin has beneficial effects such as antioxidant and anti-inflammatory effects. nanomcielle curcumin will be used in this study because of the low bioavailability , fast metabolism and low absorption of curcumin powder. Therefore, this study is planned to determine the effects of supplementation of nanomicelle curcumin on glycemic control, serum lipid profile ,blood pressure and anthropometric measurements in patients with metabolic syndrome.

Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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nanomicielle curcumin

Group Type ACTIVE_COMPARATOR

nanomicielle curcumin

Intervention Type DIETARY_SUPPLEMENT

Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomicelle curcumin or placebo. nanomcelle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.

plecebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomcielle curcumin or placebo. nanomcelle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.

Interventions

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nanomicielle curcumin

Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomicelle curcumin or placebo. nanomcelle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.

Intervention Type DIETARY_SUPPLEMENT

placebo

Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomcielle curcumin or placebo. nanomcelle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 25\<body mass index \>40
* waist circumference \>102 cm in men or \>88 cm in women
* Fasting blood glucose \>100 mg/dL
* Triglycerides (TG) \> 150 mg/dL
* High density lipoprotein cholesterol (HDL-C) \<50 in women or \<40 in men
* Systolic blood pressure (SBP) \>130 mmHg and diastolic blood pressure (DBP) \>85mmHg

Exclusion Criteria

* insulin administration for diabetes control
* hypo- or hyperthyroidism,
* renal failure or other chronic diseases
* pregnancy and breastfeeding
* taking weight loss supplements and obeying unusual weight loss plans
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Golbon Sohrab

Tehran, National Nutrition and Food Technology Research Institute, Iran

Site Status RECRUITING

Countries

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Iran

Facility Contacts

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Golbon Sohrab, ph.D

Role: primary

Zohre Bateni

Role: backup

Other Identifiers

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207

Identifier Type: -

Identifier Source: org_study_id