Trials / Unknown
UnknownNCT03558685
Weight Loss Diet in Obesity With Metabolic Syndrome
Weight Loss Diet in the Treatment of Obese Patients With the Metabolic Syndrome
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Tel-Aviv Sourasky Medical Center · Other Government
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2017-05-01
- Completion
- 2018-07-01
- First posted
- 2018-06-15
- Last updated
- 2018-06-15
Source: ClinicalTrials.gov record NCT03558685. Inclusion in this directory is not an endorsement.