Weight Loss Diet in Obesity With Metabolic Syndrome

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Obesity; Diet Modification

Treatments: Behavioral: Weight loss diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03558685

0564-08

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Diet

Experimental group

Description:

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

Treatment:

Behavioral: Weight loss diet