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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625442
• Other study ID #: 3132012
• Secondary ID: 3132012n
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2012
• Last updated: June 20, 2012
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Birjand University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 732
• Est. completion date: February 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperglycemia
• Hypertriglyceridemia
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Saffron tablet
Saffron tablets 100 mg
• Barberry tablet
Barberry tablets 200 mg
• Placebo
Placebo tablets received daily for 45 days

Locations

Country	Name	City	State
Iran, Islamic Republic of	Birjand University of medical sciences	Birjand	South khorasan

Sponsors (1)

Lead Sponsor	Collaborator
Birjand University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum LDL cholesterol	Serum LDL cholesterol after 45 days of treatment in three study groups	after 45 days of treatment	No
Secondary	Serum total cholesterol	Serum total cholesterol after 45 days of treatment in three study groups	after 45 days of treatment	No
Secondary	serum HDL cholesterol	serum HDL cholesterol after 45 days of treatment in three study groups	after 45 days of treatment	No
Secondary	serum triglyceride	serum triglyceride after 45 days of treatment in three study groups	after 45 days of treatment	No
Secondary	Fasting Blood Sugar	Fasting Blood Sugar after 45 days of treatment in three study groups	after 45 days of treatment	No
Secondary	Hematocrit	Hematocrit measured after 45 days of treatment	after 45 days of treatment	No