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

NCT ID: NCT01625442

Last Updated: 2012-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 732 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-02-29

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.

Conditions

Metabolic Syndrome; Hypercholesterolemia; Hypertriglyceridemia; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Saffron

Saffron treatment group received saffron tablets daily for 45 days

Group Type: ACTIVE_COMPARATOR

Saffron tablet

Intervention Type: DRUG

Saffron tablets 100 mg

Barberry

Barberry group received barberry tablets daily for 45 days

Group Type: ACTIVE_COMPARATOR

Barberry tablet

Intervention Type: DRUG

Barberry tablets 200 mg

Placebo

Placebo group received placebo tablets daily for 45 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets received daily for 45 days

Interventions

Saffron tablet

Saffron tablets 100 mg

Intervention Type: DRUG

Barberry tablet

Barberry tablets 200 mg

Intervention Type: DRUG

Placebo

Placebo tablets received daily for 45 days

Intervention Type: DRUG

Other Intervention Names

crocin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Birjand University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tayyebeh Kermani, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Assistant proffessor of anatomy

Maryam Navabzadeh, M.D.

Role: STUDY_DIRECTOR

Traditional iranian medicine specialist

Gholamreza Sharifzadeh, M.S.

Role: PRINCIPAL_INVESTIGATOR

Biostatistician

Javad Hadinia, B.S.

Role: PRINCIPAL_INVESTIGATOR

Traditional iranian medicine practitioner

Narges Saffari, B.S.

Role: PRINCIPAL_INVESTIGATOR

Health technician

Mohammad Khodashenas Roudsari, M.D.

Role: STUDY_CHAIR

Assistant proffessor of internal medicine

Locations

Birjand University of medical sciences

Birjand, South Khorasan Province, Iran

Countries

Iran

Other Identifiers

3132012n

Identifier Type: OTHER

Identifier Source: secondary_id

3132012

Identifier Type: -

Identifier Source: org_study_id