Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) in Metabolic Syndrome
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome Hypercholesterolemia Hypertriglyceridemia Hyperglycemia |
Drug: Saffron tablet Drug: Barberry tablet Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effect of Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) on Metabolic Syndrome |
- Serum LDL cholesterol [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]Serum LDL cholesterol after 45 days of treatment in three study groups
- Serum total cholesterol [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]Serum total cholesterol after 45 days of treatment in three study groups
- serum HDL cholesterol [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]serum HDL cholesterol after 45 days of treatment in three study groups
- serum triglyceride [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]serum triglyceride after 45 days of treatment in three study groups
- Fasting Blood Sugar [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]Fasting Blood Sugar after 45 days of treatment in three study groups
- Hematocrit [ Time Frame: after 45 days of treatment ] [ Designated as safety issue: No ]Hematocrit measured after 45 days of treatment
| Enrollment: | 732 |
| Study Start Date: | January 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Saffron
Saffron treatment group received saffron tablets daily for 45 days
|
Drug: Saffron tablet
Saffron tablets 100 mg
Other Name: 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Iran, Islamic Republic of | |
| Birjand University of medical sciences | |
| Birjand, South khorasan, Iran, Islamic Republic of, 9714815395 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Birjand University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01625442 History of Changes |
| Other Study ID Numbers: | 3132012, 3132012n |
| Study First Received: | June 19, 2012 |
| Last Updated: | June 20, 2012 |
| Health Authority: | Iran: Ministry of Health |
Keywords provided by Birjand University of Medical Sciences:
|
Metabolic syndrome hypercholesterolemia hypertriglyceridemia hyperglycemia |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperglycemia Hypertriglyceridemia Metabolic Syndrome X Hyperlipidemias Dyslipidemias |
Lipid Metabolism Disorders Metabolic Diseases Glucose Metabolism Disorders Insulin Resistance Hyperinsulinism |
ClinicalTrials.gov processed this record on May 19, 2013