Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients

NCT02259244 | Completed

• 1 other identifier: 006-0000000-3521
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Oxidative stress

  The outcome measure is studied at baseline, 1 and 12 months

Secondary Outcomes (9)

• 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

Study Arms (2)

Mediterranean diet+physical activity

EXPERIMENTAL

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

Hypolipemic reduction diet+physical activity

ACTIVE COMPARATOR

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

Interventions

Weight reduction program BEHAVIORAL

Hypolipemic reduction diet+physical activity; Mediterranean diet+physical activity

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥ 30 kg/m2

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zagreb: lead
• University Hospital Dubrava: collaborator

MeSH Terms

Conditions

Obesity

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Promotion; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Endocrinology, Diabetes and Metabolism Disorders, Dubrava University Hospital

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 8, 2014
• Study Start: October 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 8, 2014

Record last verified: 2014-10