Metabolic Syndrome (MeTS) Nutritional, Metabolic, Endocrine Metabolic Syndrome (MeTS)
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-83 years old 2. Caucasian 3. Have the following range values of serum cholesterol parameters at baseline: 3.1. TC, 200-260 mg/dL 3.2. HDL-C, 31-45 mg/dL 3.3. LDL-C, 190-205 mg/dL 3.4. TG, 170-280 mg/dL 4. Body mass index (BMI) between 18 and 30 kg/m2
Exclusion criteria
Exclusion criteria: 1. Smoking 2. Obesity (BMI >30 kg/m2) 3. Diabetes 4. Hepatic disease 5. Renal disease 6. Heart disease 7. Family history of chronic diseases 8. Drug therapy or supplement intake for hypercholesterolemia 9. Drug therapy or supplement intake containing apple polyphenols 10. Heavy physical exercise (more than10 hours per week) 11. Pregnant women, women suspected of being pregnant, women who hoped to become pregnant, breastfeeding 12. Birch pollen allergy 13. Use of vitamin/mineral supplements 2 weeks prior to entry into the study 14. Donation of blood less than 3 months before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plasma TC is measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks 2. HDL-C is measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks 3. LDL-C is measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks 4. Triglyceride levels are measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical history is measured by interviews and previous clinical data at baseline 2. Anthropometric measures are measured by taking height and weight at baseline, 4, 8, 12 and 16 weeks 3. Nutrient intake and dietary habits are measured using a seven day food record validated nutritional questionnaire at baseline, 4, 8, 12 and 16 weeks 4. Blood pressure is measured using a blood pressure cuff at baseline, 4, 8, 12 and 16 weeks 5. 24 hour ambulatory blood pressure is measured using blood pressure cuff at baseline, 4, 8, 12 and 16 weeks 6. Blood levels (AST, ALT, ?-GTP, ALP, LDH, Albumin, Total bilirubin, Creatinine) are measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks | — |
Countries
Italy