Weight Loss Diet in Obesity With Metabolic Syndrome

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03558685
• Other study ID #: 0564-08
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2008
• Est. completion date: July 2018

Study information

• Verified date: June 2018
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Modification
• Metabolic Syndrome X
• Obesity
• Weight Loss

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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.