Effects of Annurca apple polyphenols on cholesterol metabolism in healthy subjects

Evaluation of Annurca apple polyphenols on cholesterol metabolism in mildly hypercholesterolemic healthy subjects: a monocentric, randomised, cross-over, placebo-controlled 4 weeks study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15653394

Enrollment

500

Registered

2015-11-18

Start date

2015-11-23

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome (MeTS) Nutritional, Metabolic, Endocrine

Interventions

The study is a monocentric, randomised, cross-over, placebo-controlled 4 weeks study on 500 mildly hypercholesterolemic healthy volunteers, 284 men and 266 women. The subjects enrolled in this stud

HDL-C, 31-45 mg/dL

LDL-C, 189-206 mg/dL. The subjects are asked to keep their dietary habits unchanged throughout the entire study. After going though a 4 week "placebo" period, patients are randomly divided into six g

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, 31-45 mg/dL 3. LDL-C, 190-205 mg/dL. 4. 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
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. 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. All variables (primary and secondary outcomes) will be measured at baseline and after each intervention period.	—

Measure

Time frame

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. 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. All variables (primary and secondary outcomes) will be measured at baseline and after each intervention period.

—

Secondary

Measure	Time frame
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). 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.	—

Measure

Time frame

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). 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.

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026