Metabolic Syndrome
Conditions
Brief summary
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.
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 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.
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 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.
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
Yes
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 |
|---|---|
| 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 |
Countries
Iran
Outcome results
None listed