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NCT03514667 Clinical Trial

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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03514667
Other study ID # 188
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 30, 2018
Est. completion date January 30, 2020

Study information
Verified date July 2018
Source National Nutrition and Food Technology Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 30, 2020
Est. primary completion date August 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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
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.

Locations
Country Name City State
Iran, Islamic Republic of Golbon Sohrab Tehran National Nutrition And Food Technology Research Institute

Sponsors (1)
Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum Total antioxidant capacity (TAC) 12 weeks
Primary Serum Malondialdehyde (MDA) 12weeks
Primary Serum C-reactive protein (CRP) 12weeks
Primary Serum Adiponectin 12weeks
Primary NF-kB(p65) transcription in PBMC 12weeks
Primary Serum curcumin 12 weeks
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