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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514667
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: nanomicielle curcumin Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: 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
Estimated Study Start Date : August 30, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: intervention group
80 mg nanomicielle curcumin capsules once a day for 12 weeks
Dietary Supplement: 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 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.

Placebo Comparator: control group
placebo capsules once a day for 12 weeks
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 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.




Primary Outcome Measures :
  1. Serum Total antioxidant capacity (TAC) [ Time Frame: 12 weeks ]
  2. Serum Malondialdehyde (MDA) [ Time Frame: 12weeks ]
  3. Serum C-reactive protein (CRP) [ Time Frame: 12weeks ]
  4. Serum Adiponectin [ Time Frame: 12weeks ]
  5. NF-kB(p65) transcription in PBMC [ Time Frame: 12weeks ]
  6. Serum curcumin [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514667


Locations
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Iran, Islamic Republic of
Golbon Sohrab Recruiting
Tehran, National Nutrition And Food Technology Research Institute, Iran, Islamic Republic of
Contact: golbon sohrab, ph.D    009802122077424    golbonsohrab@yahoo.com   
Contact: zohre bateni    009809129626018    zohre.bateni@yahoo.com   
Sponsors and Collaborators
National Nutrition and Food Technology Institute

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Responsible Party: Dr Azita Hekmatdoost, clinical professor, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT03514667    
Other Study ID Numbers: 188
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Inflammation
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action