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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Metabolic Syndrome; Hypercholesterolemia; Hypertriglyceridemia
• Intervention / Treatment: Drug: Saffron tablet; Drug: Barberry tablet; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 732
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • South khorasan
    • Birjand, South khorasan, Iran, Islamic Republic of, 9714815395
      • Birjand University of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Saffron; Saffron treatment group received saffron tablets daily for 45 days	Drug: Saffron tablet; Saffron tablets 100 mg; Other Names: crocin
Active Comparator: Barberry; Barberry group received barberry tablets daily for 45 days	Drug: Barberry tablet; Barberry tablets 200 mg
Placebo Comparator: Placebo; Placebo group received placebo tablets daily for 45 days	Drug: Placebo; Placebo tablets received daily for 45 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Birjand University of Medical Sciences
• Investigators: Principal Investigator: Tayyebeh Kermani, Ph.D., Assistant proffessor of anatomy; Study Director: Maryam Navabzadeh, M.D., Traditional iranian medicine specialist; Principal Investigator: Gholamreza Sharifzadeh, M.S., Biostatistician; Principal Investigator: Javad Hadinia, B.S., Traditional iranian medicine practitioner; Principal Investigator: Narges Saffari, B.S., Health technician; Study Chair: mohammad khodashenas roudsari, M.D., assistant proffessor of internal medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: June 20, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Estimate): June 21, 2012
• Last Update Submitted That Met QC Criteria: June 20, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Metabolic syndrome; hypertriglyceridemia; hyperglycemia; hypercholesterolemia
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hyperglycemia; Syndrome; Metabolic Syndrome; Hypercholesterolemia; Hypertriglyceridemia
• Other Study ID Numbers: 3132012; 3132012n (Other Identifier: birjand university of medical sciences)