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

Phase 4

Completed

• Conditions: Metabolic Syndrome; Hypercholesterolemia; Hypertriglyceridemia; Hyperglycemia
• Interventions: Drug: Saffron tablet; Drug: Barberry tablet; Drug: Placebo

• Registration Number: NCT01625442
• Lead Sponsor: Birjand University of Medical Sciences

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-07
• Study Completion: 2012-02
• Status Verified: 2012-06
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Last Update Submitted: 2012-06-20
• Study First Posted: 2012-06-21
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 732

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saffron	Saffron tablet	Saffron treatment group received saffron tablets daily for 45 days
Barberry	Barberry tablet	Barberry group received barberry tablets daily for 45 days
Placebo	Placebo	Placebo group received placebo tablets daily for 45 days

Primary Outcome Measures

Name	Time	Method
Serum LDL cholesterol	after 45 days of treatment	Serum LDL cholesterol after 45 days of treatment in three study groups

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Birjand University of medical sciences; 🇮🇷 Birjand, South khorasan, Iran, Islamic Republic of