Effects of Annurca apple polyphenols on cholesterol metabolism in healthy subjects

Completed

Conditions: Metabolic Syndrome (MeTS)
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN15653394

Lead Sponsor: Hospital AO Rummo

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 500

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, 31-45 mg/dL
3. LDL-C, 190-205 mg/dL.
4. Body mass index (BMI) between 18 and 30 kg/m2

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Plasma TC, HDL-C, and LDL-C levels are determined at the beginning (week -4) of the trial, after the placebo period (week 0), and at the end of the interventional study (week 4). Analyses are performed on a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), by using commercially available kits from Diacron International.<br>2. Higher positive effects on the balance of plasma cholesterol parameters, as regards the apple interventional study, are expected in the subjects belonging to group ANN in comparison to the others groups.<br><br>All variables (primary and secondary outcomes) will be measured at baseline and after each intervention period.

Secondary Outcome Measures

Name	Time	Method
1. At the beginning and end of each intervention period a medical assessment will be performed which included: clinical history, dietary evaluation, anthropometric measures, clinical blood pressure and 24-hour ambulatory blood pressure, blood analysis (TC, HDL-C, LDL-C, AST, ALT, ?-GTP, ALP, LDH, Albumin, Total bilirubin, Creatinine).<br>2. A 7-day food record validated nutritional questionnaire will be used at the beginning and end of the intervention to assess nutrient intake and to monitor the dietary habits.