Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients

NCT ID: NCT02259244

Last Updated: 2014-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2013-10-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Mediterranean diet+physical activity

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

Group Type: EXPERIMENTAL

Weight reduction program

Intervention Type: BEHAVIORAL

Hypolipemic reduction diet+physical activity

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

Group Type: ACTIVE_COMPARATOR

Weight reduction program

Intervention Type: BEHAVIORAL

Interventions

Weight reduction program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Dubrava

OTHER

Sponsor Role: collaborator

University of Zagreb

OTHER

Sponsor Role: lead

Responsible Party

Prof. dr. sc. Velimir Božikov

Head of the Department of Endocrinology, Diabetes and Metabolism Disorders, Dubrava University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

006-0000000-3521

Identifier Type: -

Identifier Source: org_study_id