Effect of Weight Loss on Cholesterol Metabolism in Hereditary Hypercholesterolemias and Overweight or Obesity.
Familial Hypercholesterolemias, Weight Loss, Familial Combined Hypercholesterolemia
About this trial
This is an interventional treatment trial for Familial Hypercholesterolemias focused on measuring Familial Hypercholesterolemia, Familial Combined Hypercholesterolemia, Weight loss; Lipids; Phytosterols, Obesity, Overweight., Lipids
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of Familial Combined Hyperlipidemia* and Familial Hypercholesterolemia**.
- Body mass index > 25 kg/m2.
- Steady weight (±3 kg in the last 3 months).
Absence of lipid lowering drugs including sterols supplements in the previous 5 weeks.
Familial Combined Hyperlipidemia diagnosis was based on the presence of primary combined hyperlipidaemia in untreated patients whose serum cholesterol and triglyceride concentrations were above the sex- and age-specific 90th percentiles for the Spanish population, serum total apolipoprotein B concentration ≥ 120 mg/dL and there was at least one first-degree relative with hyperlipidemia (total cholesterol and/or triglycerides >90th percentile) (Gómez-Gerique JA et al; 1999).
- Familial Hypercholesterolemia was diagnosed in subjects with off-treatment LDL cholesterol concentrations above the age- and sex-specific 95th percentile of a Spanish reference population, triglyceride below 200 mg/dL and familial vertical transmission with at least one first-degree relative with LDL cholesterol above age- and sex-specific 95th percentiles (Gómez-Gerique JA et al; 1999).
Exclusion Criteria:
- Alcohol consumption >30 gr/day.
- Uncontrolled type-2 diabetes (HbA1c >8%).
- Any other disease that could interfere with the ability to comply with the study protocol were excluded
- Personal history of cardiovascular disease, very high risk as defined by the presence of ≥ 2 major risk factors, or total cholesterol ≥ 350 mg/dL since lipid-lowering drug were considered highly recommended.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Weight loss and dietary intervention
The weight loss intervention had a total duration of 6 months. Each participant's caloric prescription represented a deficit of 600 kcal per day as calculated from the person's resting energy expenditure and activity level using the Harris-Benedict equation. In general, prescribed energy intake was between 1200 kcal and 1600 kcal/day. Dietary composition consisted on 50-55% of carbohydrates, 15-20% of protein and 30% of fat and included a wide variety of foods typical of a Mediterranean diet. Patients were also provided with recipes and shopping counselling to improve intervention compliance and to achieve the weight loss goal. Individual consultations with a nutritionist were performed twice a month to motivate the weight loss and reinforce the intervention.