Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients
Not Applicable
Completed
- Conditions
- Obesity
- Interventions
- Behavioral: Weight reduction program
- Registration Number
- NCT02259244
- Lead Sponsor
- University of Zagreb
- Brief Summary
The purpose of this study is to evaluate the combined effect of physical activity and adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative stress in obese patients enrolled in the weight management reduction program.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
- BMI ≥ 30 kg/m2
Exclusion Criteria
- newly diagnosed diabetes, hypertension or cardiovascular disease
- change in antihypertensive therapy and antidiabetic therapy in the period of 3 months prior to the commencement of the study
- insulin therapy
- alcohol consumption >500 g of alcohol/week in the last year
- pregnancy or breast feeding
- use of drugs affecting weight control (eg. weight loss medication or systemic glucocorticoids)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mediterranean diet+physical activity Weight reduction program Mediterranean diet based on 1573 kcal/day with the goal of consumption of 30 ml/day of olive oil, 56g/week of nuts, 3-4 servings/week of fish, 3 servings/day of fruits, 2-3 servings/day of vegetables, 3 servings/week legumes and white meat instead of red meat Hypolipemic reduction diet+physical activity Weight reduction program Hypolipemic reduction diet based on 1287 kcal/day with the goal of consumption of 3 servings/day of fruits, 2-3 servings/day of vegetables, 3 servings/week legumes and white meat instead of red meat, non-fat or low-fat dairy products
- Primary Outcome Measures
Name Time Method Oxidative stress The outcome measure is studied at baseline, 1 and 12 months
- Secondary Outcome Measures
Name Time Method Body weight (kg) The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months Waist circumference (cm) The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months Fasting glycemia The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months Lipid profile (HLD, LDL, TC,) The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months Urate The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months Blood pressure (mmHg) The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months Physical activity level The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months IPAQ-SF for record on physical activity during 7 last 7 days.
Quality of life The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months SF-36 questionnaire
Dietary intakes The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months Food Frequency Questionnaire 7-day food diary