The Effects of Nanocurcumin on Serum Oxidative Stress,Inflammation,Adiponectin and NF-kB in Blood Mononuclear Cells in Metabolic Syndrome Patients (Nuclear Factor-κB)

Study Overview
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Brief Summary
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Metabolic syndrome is a public health challenge that includes a range of conditions including abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. The syndrome is associated with an increase in the risk of Cardiovascular disease and death. Curcumin is a very active compound obtained from turmeric root. Curcumin has antioxidant and anti-inflammatory effects, and is also involved in the regulation of several signaling pathways. Since curcumin powder has low bioavailability, fast metabolism and low absorption, nanomicielle curcumin will be used in this study. Therefore, this study is planned to determine the effects of supplementation of nanomicielle curcumin on oxidative stress, systemic inflammation, adiponectin in serum and NF-kB in peripheral blood mononuclear cells in patients with metabolic syndrome.

Official Title
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The Effects of Nanomicielle Curcumin on Oxidative Stress, Systemic Inflammation, Adiponectin in Serum and NF-kB in Blood Mononuclear Cells, 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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No

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: intervention group<br>80 mg nanomicielle curcumin capsules once a day for 12 weeks | 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 nanomicielle curcumin or placebo. nanomicielle 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: control group<br>placebo capsules once a day for 12 weeks | 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 nanomicielle curcumin or placebo. nanomicielle 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 |
| --- | --- | --- |
| Serum Total antioxidant capacity (TAC) |  | 12 weeks | 
| Serum Malondialdehyde (MDA) |  | 12weeks | 
| Serum C-reactive protein (CRP) |  | 12weeks | 
| Serum Adiponectin |  | 12weeks | 
| NF-kB(p65) transcription in PBMC |  | 12weeks | 
| Serum curcumin |  | 12 weeks |