Weight Loss Diet in Obesity With Metabolic Syndrome

Not Applicable

• Conditions: Obesity; Diet Modification
• Interventions: Behavioral: Weight loss diet

• Registration Number: NCT03558685
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2017-05
• Study First Submitted: 2018-05-31
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-14
• Last Update Submitted: 2018-06-14
• Study First Posted: 2018-06-15
• Last Update Posted: 2018-06-15
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diet	Weight loss diet	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

Primary Outcome Measures

Name	Time	Method
% BMI Change	One Year, from the initiation of the intervention to its termination.	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%.