Weight Loss Diet in Obesity With Metabolic Syndrome

Study Overview
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Brief Summary
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Concomitant interventions included lifestyle modification with a personally tailored program of diet as detailed below and physical activity adjusted for age and specific physical limitations, targeting engagement in physical activity of at least 150 minutes/week. Lipid lowering and or blood pressure lowering drugs were prescribed as needed according to guideline-assisted medical practice. Patients were seen by a physician every 3 month. The dietitian had a weekly meeting with the patients for the first three months, every other week during months 4-6, once a month during month 7-9 and every 6 weeks during the last three months of the study.

Official Title
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Weight Loss Diet in the Treatment of Obese Patients With the Metabolic Syndrome

Conditions
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Obesity, Diet Modification

Intervention / Treatment
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* Behavioral: Weight loss diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - fulfilled the diagnostic criteria for the metabolic syndrome as defined by the Third Report of the Adult Treatment Panel (ATPIII). Exclusion Criteria: diabetes the presence of current or recent pregnancy or intention to conceive within the trial's period chronic renal or liver disease past bariatric surgery current participation in any dietary/ medical program with current continuous weight loss.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet<br>Nutritional recommendation consisted of moderate caloric restriction, set at 25% to 30% less than calories needed for resting metabolic rate. We applied a high protein Mediterranean diet with the following food group distribution: 30% as protein (> 0.8 g/kg/d); 40% as carbohydrates with medium/low glycemic index; 30% as fat (≥10%monounsaturated fatty acid, ≤7% saturated fatty acid, no trans fats, and 1.6 g omega-3 for men and 1.1 g omega-3 for women). Diet was rich in olive oil, fish, chicken, nuts, white milk products, fruits, and vegetables but low in artificial sugars, commercial sweets, pastries, butter, margarine, and red meat. Dietary fiber content ≥25 g/day | Behavioral: Weight loss diet<br>* Nutritional recommendation consisted of moderate caloric restriction, set at 25% to 30% less than calories needed for resting metabolic rate. We applied a high protein Mediterranean diet with the following food group distribution: 30% as protein (> 0.8 g/kg/d); 40% as carbohydrates with medium/low glycemic index; 30% as fat (≥10% monounsaturated fatty acid, ≤7% saturated fatty acid, no trans fats, and 1.6 g omega-3 for men and 1.1 g omega-3 for women). Diet was rich in olive oil, fish, chicken, nuts, white milk products, fruits, and vegetables but low in artificial sugars, commercial sweets, pastries, butter, margarine, and red meat. Dietary fiber content ≥25 g/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % BMI Change | BMI is calculated as weight in Kg divided by height in meters X height in meters. Percent change will be calculated as the difference in BMI units (kg/m2) between the final BMI and the initial BMI, divided by the initial BMI, multiplied by 100%. | One Year, from the initiation of the intervention to its termination. |