Metabolic syndrome Nutritional, Metabolic, Endocrine Other metabolic disorders
Conditions
Interventions
Control period:
Patients are put under basic alimentary roles of a balanced diet, except for the total absence of fish intake. This will last for 8 weeks.
Intervention period:
Patients are put unde
Sponsors
Pescanova S.A. (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years, either sex 2. Recruited in outpatients clinics of the participant centres 3. Voluntarily agree with the study protocol and give written informed consent 4. Thorough clinical history and informative meeting has been performed 5. Metabolic syndrome (primary intervention). The presence of metabolic syndrome according to 2004 ATP-III (Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults) criteria will be evaluated. According to the latter, for the diagnosis of the metabolic syndrome, three or more of the following criteria have to be present: 5.1. Central obesity: waist circumference greater than 102 cm in men and greater than 88 cm in women 5.2. Hypertriglyceridemia: triglycerides greater than or equal to 150 mg/dL (greater than or equal to 1.7 mmol/L) or on treatment 5.3. High density lipoprotein (HDL) less than 40 mg/dL (less than 1.1 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women 5.4. Hypertension: systolic blood pressure greater than or equal to 130 mmHg and/or diastolic greater than or equal to 85 mmHg, or on treatment 5.5. Fasting blood glucose greater than or equal to 100 mg/dL (greater than or equal to 5.6 mmol/L) or any other carbohydrate metabolism disorder (including diabetes and glucose intolerance)
Exclusion criteria
Exclusion criteria: Those who presented any of the following after a thorough clinical history: 1. Previous allergy to fish or Anisakis infection 2. Morbid obesity (body mass index [BMI] greater than 40) 3. Chronic renal failure 4. Creatinine clearance (CrCl) greater than 30 5. Chronic psychopathology 6. Malignancy 7. Refuse to participate 8. Fibrates treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum triglyceride concentrations, measured at the inclusion time and at the end of each intervention period (3 measurements altogether) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at the inclusion time and at the end of each intervention period (3 measurements altogether): 1. Other components of the metabolic syndrome as defined by the ATP III 2. Anthropometric variables: height, weight, waist and hip circumferences 3. Biochemical markers and chronic inflammation markers 4. Adherence and feasibility of the nutritional intervention 5. Erythrocyte membrane omega-3 concentrations 6. Insulin resistance (Homeostatic Model Assessment [HOMA]) | — |
Countries
Spain
Outcome results
None listed