Obesity and Metabolic Syndrome. Obesity due to excess calories
Conditions
Interventions
Intervention 1: In intervention group supplementation with 100 mg saffron per day in capsule form was done for 12 weeks. Intervention 2: In positive control group supplementation with 100 mg placebo (
Treatment - Drugs
In intervention group supplementation with 100 mg saffron per day in capsule form was done for 12 weeks.
In positive control group supplementation with 100 mg placebo (starch) per day in capsule form was done for 12 weeks.
In negative control group dietary advices according to the American heart association guideline was done.
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: age between 18 to 75 years old; resident in Mashhad city; consent to participate; criteria of Metabolic syndrome based on the IDF criteria (Waist circumference >94 cm in men and > 80 cm in women) plus two of the following four: 1: FBS>100 mg/dl, 2: TG>150 mg/dl, 3: systolic blood pressure> 130 mm hg or diastolic blood pressure> 85 mm hg or usage of anti-hypertension drugs, 4: HDL< 40 mg/dl in men and < 50 mg/dl in women. Exclusion criteria: age lower than 18 and higher than 75 years old; pregnancy or Lactation; systematic disease such as lupus and arthritis; not regular capsule consumption; intolerant saffron pill; lack of cooperation and regular evaluation
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure. Timepoint: Baseline-day 42- day 84. Method of measurement: Systolic and diastolic blood pressure according to standard protocols, were measured.Blood pressure was measured in a sitting position and in the absence of self examination, at least 5 minutes before measuring their blood pressure, complete rest.;Serum Leptin. Timepoint: baseline-day 84. Method of measurement: ELISA.;Lipid profile. Timepoint: baseline-day 84. Method of measurement: authoanalyzer BT3000.;Fasting plasma glucose. Timepoint: baseline-day 84. Method of measurement: authoanalyzer BT3000.;Anti-HSP antibodies. Timepoint: baseline-day 84. Method of measurement: ELISA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal complications of Saffron pill. Timepoint: end of the study. Method of measurement: Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Majid Ghayour-Mobarhan
Nutrition group of Mashhad University of Medical Sciences
Outcome results
None listed