Clinical trial NCT01625442: Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) in Metabolic Syndrome
Official title: Effect of Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) on Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Hypercholesterolemia
Hypertriglyceridemia
Hyperglycemia
Keywords: Metabolic syndrome
hypercholesterolemia
hypertriglyceridemia
hyperglycemia
Lead sponsor: Birjand University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serum LDL cholesterol
timeFrame: after 45 days of treatment
Secondary outcomes:
measure: Serum total cholesterol
timeFrame: after 45 days of treatment
measure: serum HDL cholesterol
timeFrame: after 45 days of treatment
measure: serum triglyceride
timeFrame: after 45 days of treatment
measure: Fasting Blood Sugar
timeFrame: after 45 days of treatment
measure: Hematocrit
timeFrame: after 45 days of treatment
Other outcomes:
Locations:
city: Birjand
country: Iran, Islamic Republic of
facility: Birjand University of medical sciences
state: South khorasan
Study officials:
affiliation: Assistant proffessor of anatomy
name: Tayyebeh Kermani, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Traditional iranian medicine specialist
name: Maryam Navabzadeh, M.D.
role: STUDY_DIRECTOR
affiliation: Biostatistician
name: Gholamreza Sharifzadeh, M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Traditional iranian medicine practitioner
name: Javad Hadinia, B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Health technician
name: Narges Saffari, B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant proffessor of internal medicine
name: Mohammad Khodashenas Roudsari, M.D.
role: STUDY_CHAIR
References: