Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) in Metabolic Syndrome

Study Overview
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Brief Summary
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The metabolic syndrome is associated with increased risk of cardiovascular disease and diabetes mellitus. The age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for women. Emerging alternative medicine worldwide led investigators to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. Serum total cholesterol, serum LDL cholesterol, serum HDL cholesterol, serum triglyceride, Fasting Blood Sugar and hematocrit measured before and after 45 days of treatment.

Detailed Description
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In a randomized, placebo controlled, single-blind , efficacy trial with three treatment arms the investigators randomly assigned 105 patients with metabolic syndrome to receive barberry juice, saffron juice or placebo tablet. The aim was to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. The metabolic syndrome (syndrome X, insulin resistance syndrome) consists of a constellation of metabolic abnormalities that confer increased risk of cardiovascular disease (CVD) and diabetes mellitus (DM). The major features of the metabolic syndrome include central obesity hypertriglyceridemia, low HDL cholesterol, hyperglycemia, and hypertension. Based on data from the National Health and Nutrition Examination Survey (NHANES) III, the age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for Women. Review of literature revealed anti-inflammatory, radical-scavenging, antioxidant, cytoprotective, beneficial cardiovascular and neural system effects for saffron, potential use for treatment of hypertension, tachycardia and some neuronal disorders, such as epilepsy and convulsion, antihypertensive and vasodilatory activities. Barberry has promising and selective anti-cancer activities, beneficial effects in atherosclerosis, arthritis, coronary heart disease and hepatitis, hypotensive property and to promote immunity, prevention of insulin resistance and related diseases, neuroprotective, hypolipidemic and antioxidant properties for saffron in animal models.

Official Title
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Effect of Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) on Metabolic Syndrome

Conditions
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Metabolic Syndrome, Hypercholesterolemia, Hypertriglyceridemia, Hyperglycemia

Intervention / Treatment
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* Drug: Saffron tablet
* Drug: Barberry tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: waist circumference of ≥ 94 cm (males) or ≥ 80 cm (females) plus any two of the following: blood pressure ≥ 130/85 or taking antihypertensive medication, fasting plasma glucose (FPG) > 100 mg/dL, serum triglycerides (TG) > 150 mg/dL, high-density lipoprotein (HDL) < 40 mg/dL in men,and < 50 mg/dL in women- Exclusion Criteria: using insulin or glucose sensitizing medication preexisting cardiovascular disease psychiatric problems non-compliance of patients not presenting at times determined for treatment and evaluation

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saffron<br>Saffron treatment group received saffron tablets daily for 45 days | Drug: Saffron tablet<br>* Saffron tablets 100 mg<br>* Other names: crocin;|
| Active Comparator: Barberry<br>Barberry group received barberry tablets daily for 45 days | Drug: Barberry tablet<br>* Barberry tablets 200 mg<br>|
| Placebo Comparator: Placebo<br>Placebo group received placebo tablets daily for 45 days | Drug: Placebo<br>* Placebo tablets received daily for 45 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum LDL cholesterol | Serum LDL cholesterol after 45 days of treatment in three study groups | after 45 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum total cholesterol | Serum total cholesterol after 45 days of treatment in three study groups | after 45 days of treatment | 
| serum HDL cholesterol | serum HDL cholesterol after 45 days of treatment in three study groups | after 45 days of treatment | 
| serum triglyceride | serum triglyceride after 45 days of treatment in three study groups | after 45 days of treatment | 
| Fasting Blood Sugar | Fasting Blood Sugar after 45 days of treatment in three study groups | after 45 days of treatment | 
| Hematocrit | Hematocrit measured after 45 days of treatment | after 45 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome, hypercholesterolemia, hypertriglyceridemia, hyperglycemia