Effects of Annurca apple polyphenols on cholesterol metabolism in healthy subjects

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN15653394
• Date of registration: 18/11/2015
• Prospective Registration: Yes
• Primary sponsor: Hospital AO Rummo
• Public title: Effects of Annurca apple polyphenols on cholesterol metabolism in healthy subjects
• Scientific title: Evaluation of Annurca apple polyphenols on cholesterol metabolism in mildly hypercholesterolemic healthy subjects: a monocentric, randomised, cross-over, placebo-controlled 4 weeks study
• Date of first enrolment: 23/11/2015
• Target sample size: 500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15653394
• Study type: Interventional
• Study design: Intervention trial, parallel, randomized, open and controlled (Prevention)

Countries of recruitment

Italy

Contacts

• Name: Gian Carlo Tenore

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic Syndrome (MeTS)
Nutritional, Metabolic, Endocrine

Intervention(s)

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 study have the following values of serum cholesterol parameters at baseline (week 0): TC, 200-260 mg/dL; 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 groups. Four groups are assigned to consume one apple/day among the following: Red Delicious, Granny Smith, Fuji, Golden Delicious. The fifth group is asked to consume two Annurca apples/day, since the weight of this cultivar is on average the half of the commercial ones considered in this study. The sixth group is given two gastric-resistant capsules containing Annurca apple polyphenolic extract, accounting for 800 mg/day. After one month, all participants go though another "placebo" period of 4 weeks before being randomly assigned to one of the other treatment groups for a further 4 weeks.

Blood samples of volunteers are collected after 12 h of fasting at week -4, 0, and 4 and are analysed to monitor the lipid profile (TC, LDL-C, and HDL-C) and hepatic and renal function.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

18.07.2015 14303

Source(s) of Monetary Support

Samnium Medical Cooperative (Italy), University of Naples “Federico II” (Naples, Italy).