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

Study Overview
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: nanomicielle curcumin
* Dietary Supplement: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nanomicielle curcumin<br> | Dietary Supplement: nanomicielle curcumin<br>* 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.<br>|
| Placebo Comparator: plecebo<br> | Dietary Supplement: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin A1c (HbA1c) |  | 12 weeks | 
| serum glucose |  | 12weeks | 
| serum insulin |  | 12weeks | 
| homeostatic model assessment of insulin resistance(HOMA-IR) |  | 12weeks | 
| homeostatic model assessment of beta cell(HOMA-B) |  | 12weeks | 
| serum triglyceride (TG) |  | 12 weeks | 
| serum total Cholesterol |  | 12 weeks | 
| serum LDL-C |  | 12 weeks | 
| serum HDL-C |  | 12 weeks | 
| systolic blood pressure |  | 12 weeks | 
| diastolic blood pressure |  | 12 weeks | 
| serum curcumin |  | 12 weeks |