Metabolic Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTnanomicielle 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.
DIETARY_SUPPLEMENTplacebo
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.
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Iran
Outcome results
None listed