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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Birjand University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01625442
First received: June 19, 2012
Last updated: June 20, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Birjand University of Medical Sciences:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625442

Locations
Iran, Islamic Republic of
Birjand University of medical sciences
Birjand, South khorasan, Iran, Islamic Republic of, 9714815395
Sponsors and Collaborators
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
  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 August 26, 2014