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

Birjand University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia; Hypertriglyceridemia; Hypercholesterolemia; Metabolic Syndrome

Treatments: Drug: Saffron tablet; Drug: Placebo; Drug: Barberry tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT01625442

3132012n (Other Identifier)

3132012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 732 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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732 participants in 3 patient groups, including a placebo group

Saffron

Active Comparator group

Description:

Saffron treatment group received saffron tablets daily for 45 days

Treatment:

Drug: Saffron tablet

Barberry

Active Comparator group

Description:

Barberry group received barberry tablets daily for 45 days

Treatment:

Drug: Barberry tablet

Placebo

Placebo Comparator group

Description:

Placebo group received placebo tablets daily for 45 days

Treatment:

Drug: Placebo