Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Weight reduction program

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Weight reduction program
Active Comparator: 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	Behavioral: Weight reduction program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Zagreb
• Collaborators: University Hospital Dubrava

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: October 3, 2014
• First Posted (Estimate): October 8, 2014

Study Record Updates

• Last Update Posted (Estimate): October 8, 2014
• Last Update Submitted That Met QC Criteria: October 3, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 006-0000000-3521