Hypercholesterolemia, Hyperglycemia, Hypertriglyceridemia, Metabolic Syndrome
Conditions
Keywords
Metabolic syndrome, hypercholesterolemia, hypertriglyceridemia, hyperglycemia
Brief summary
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
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.
Interventions
DRUGSaffron tablet
Saffron tablets 100 mg
DRUGBarberry tablet
Barberry tablets 200 mg
DRUGPlacebo
Placebo tablets received daily for 45 days
Sponsors
Birjand University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum LDL cholesterol | after 45 days of treatment | Serum LDL cholesterol after 45 days of treatment in three study groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum total cholesterol | after 45 days of treatment | Serum total cholesterol after 45 days of treatment in three study groups |
| serum HDL cholesterol | after 45 days of treatment | serum HDL cholesterol after 45 days of treatment in three study groups |
| serum triglyceride | after 45 days of treatment | serum triglyceride after 45 days of treatment in three study groups |
| Fasting Blood Sugar | after 45 days of treatment | Fasting Blood Sugar after 45 days of treatment in three study groups |
| Hematocrit | after 45 days of treatment | Hematocrit measured after 45 days of treatment |
Countries
Iran
Outcome results
None listed