Metabolic Syndrome (MeTS) Nutritional, Metabolic, Endocrine Metabolic Syndrome (MeTS)
Conditions
Interventions
Participants are randomly allocated into two groups.
They are followed by a cross-over design including 7-day washout periods and 10-day treatment periods. During the treatment periods, each group ar
Sponsors
Samnium Medical Cooperative
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women between 18-83 years of age, of white race, with the following range values of serum cholesterol parameters at baseline (week 0): 1. TC, 200-260 mg/dL 2. HDL-C, 30-45 mg/dL 3. LDL-C, 189-206 mg/dL 4. TG, 170-280 mg/dL 5. Body mass index (BMI) between 18 and 30 kg/m2
Exclusion criteria
Exclusion criteria: Healthy adults (males and females) with: 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 (>10 h/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 |
|---|---|
| Fecal samples are collected for the analysis of lipid excretion during the last three days of each treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical history is measured both by interviews and previous clinical data at baseline 2. Anthropometric measures are collected taking height and weight at baseline and at the end of the study period 3. Nutrient intake and dietary habits are measured using a seven day food record validated nutritional questionnaire at baseline and at the end of the study period 4. Blood pressure is measured using a blood pressure cuff at baseline and at the end of the study period 5. 24 hour ambulatory blood pressure is measured using blood pressure cuff at baseline and at the end of the study period 6. Plasma TC is measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International at days 8, 18, 25 and 35 of the study period 7. HDL-C is measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International at days 8, 18, 25 and 35 of the study period 8. LDL-C is measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International at days 8, 18, 25 and 35 of the study period 9. Triglyceride levels are measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International at days 8, 18, 25 and 35 of the study period 10. Blood analysis (AST, ALT, ?-GTP, ALP, LDH, Albumin, Total bilirubin, Creatinine) is measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International at days 8, 18, 25 and 35 of the study period | — |
Countries
Italy
Outcome results
None listed