Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of the Mediterranean Diet and Hypolipemic Reduction Diet in Combination With Exercise in Obese Croatian Population- 1-year Randomized Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Weight reduction program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean diet+physical activity<br>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 | Behavioral: Weight reduction program<br> <br> |
| Active Comparator: Hypolipemic reduction diet+physical activity<br>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 | Behavioral: Weight reduction program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress |  | The outcome measure is studied at baseline, 1 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | IPAQ-SF for record on physical activity during 7 last 7 days. | The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months | 
| Quality of life | SF-36 questionnaire | The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months | 
| Dietary intakes | Food Frequency Questionnaire 7-day food diary | The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months |