Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients

Not Applicable

Completed

• Conditions: Obesity

• 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

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Study First Submitted: 2014-09-23
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-03
• Last Update Submitted: 2014-10-03
• Study First Posted: 2014-10-08
• Last Update Posted: 2014-10-08

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

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