Epilobium angustifolium L. extract with high content in oenothein B on benign prostatic hyperplasia: A monocentric, randomized, double-blind, placebo-controlled clinical trial.

Benign prostatic hyperplasia (BPH) is a common condition in adult men. Especially in Europe, increasing attention has been focused on E. angustifolium extracts (EAEs), which are widely used for their positive effects on the symptoms of BPH, although human clinical trials are limited. The aim of this monocentric, randomized, double-blind, placebo-controlled clinical trial is to evaluate if a daily intake of hard, gastric-resistant capsules containing a chemically characterized EAE (500 mg) for 6 months may allow a significant improvement in symptoms in subjects with BPH. This study was conducted in 128 adult men, randomly assigned to receive either EAE food supplement (N = 70) or placebo (N = 58), who underwent four visits (baseline = t0, after 15 days = t1, after 2 months = t2 and after 6 months = t3) in an outpatient setting to evaluate post-void residual (PVR) and prostate volume (PV) by means of prostate ultrasound, prostate-specific antigen (PSA) and neutrofile/lymphocyte ratio (N/L), nocturia before the clinical visits and International Prostate Specific Score (IPSS) registered by the physicians. EAE food supplement induced a significant decrease in the PVR and consequently nocturia improving the quality of life as suggested by the decrease of IPSS. No subjects reported adverse effects related to oral intake of EAE food supplement. Moreover, EAE food supplement did not show hepatic or renal toxicity. In conclusion, EAE food supplements can be used in subjects with BPH, to improve their quality of life and general renal function.

A Pilot Screening of Agro-Food Waste Products as Sources of Nutraceutical Formulations to Improve Simulated Postprandial Glycaemia and Insulinaemia in Healthy Subjects.

The control of glucose homeostasis is the main goal for both the prevention and management of diabetes and pre-diabetes. Numerous drugs are available, despite their side effects. This is constantly leading people to be inclined to natural alternative treatments. Evidence indicates antioxidant-based nutraceuticals as an optimal tool for the glycaemic control. Currently, a great interest has been focused on the valorisation of agro-food by-products as sources of bioactive compounds including polyphenols. In this sense, we tested the efficacy of novel nutraceutical products based on polyphenolic extract from nectarines (NecP), tomato peels (TP), and olive leaves (EOL) on glycaemic and insulinemic responses. The three formulations contained, respectively, 0.007 mg abscisic acid (ABA)/g, 0.5 mg carotenoids/g, and 150 mg oleuropein/g. Twenty healthy subjects consumed a regular glucose solution (RG) or a treatment beverage (TB) obtained by mixing RG with the individual formulations (TB NecP, TB EOL, and TB TP), separately, and on different days. All three formulations significantly lowered the 30 min glucose plasma peak (p < 0.05 for all); similarly, NecP and TP also significantly lowered the 30 min insulin plasma peak (p < 0.05 for all). These results may lead to the hypothesis of a formulation of a multi-component nutraceutical with a synergistic efficacy for the glycaemic control.

Lactofermented Annurca Apple Puree as a Functional Food Indicated for the Control of Plasma Lipid and Oxidative Amine Levels: Results from a Randomised Clinical Trial.

Atherosclerotic cardiovascular diseases are preferential targets of healthy diet and preventive medicine partially through strategies to improve lipid profile and counteract oxidative metabolites. Ninety individuals with cardiovascular disease (CVD) risk factors were randomized (1:1:1 ratio) to three arms, according to a four-week run-in, eight-week intervention, and four-week follow up study, testing the effects of a lactofermented Annurca apple puree (lfAAP), compared to unfermented apple puree (AAP) or probiotic alone (LAB) on plasma lipid profile and trimethylamine-N-oxide (TMAO) levels. By comparing the treatments, data indicated for the subjects tested with lfAAP a higher variation of the following serum parameters, in respect to the other treatment groups: high density lipoprotein cholesterol (HDL-C), +61.8% (p = 0.0095); and TMAO levels, -63.1% (p = 0.0042). The present study would suggest lfAAP as an effective functional food for beneficial control of plasma HDL-C and TMAO levels.

Effect of Annurca Apple Polyphenols on Intermittent Claudication in Patients With Peripheral Artery Disease.

Peripheral arterial disease (PAD) is an atherosclerotic process involving both modifiable and nonmodifiable risk factors. Prospective cohort studies show that patients with PAD have a 6-fold greater risk of death from cardiovascular disease than those without PAD. Currently, there is no effective treatment for PAD. The study was a randomized, placebo-controlled trial, involving 180 patients, aged 35 to 75. The subjects were divided into 2 groups. One group underwent 24 weeks of nutraceutical treatment consisting in the administration of 4 capsules of Annurca apple polyphenolic extract (AMS)/day. The placebo group was administered with identically appearing capsules containing only maltodextrin. Primary outcome measures were: walking autonomy, ankle-brachial index, acceleration time. In the AMS group, at the end of the treatment period, walking autonomy was increased on average by 69% (p <0.05), while slighter effects were registered as regards ankle-brachial index (+25%; p <0.05) and acceleration time (-3.6%; p <0.05), when compared with baseline. Placebo group revealed no significant differences as regards variations of all outcomes measures (p >0.05). Our preliminary results may indicate AMS product as a promising natural and safe tool for treatment of symptoms related to PAD.

Annurca Apple Nutraceutical Formulation Enhances Keratin Expression in a Human Model of Skin and Promotes Hair Growth and Tropism in a Randomized Clinical Trial.

Several pharmaceutical products have been formulated over the past decades for the treatment of male and female alopecia, and pattern baldness, but relatively few metadata on their efficacy have been published. For these reasons, the pharmaceutical and medical attention has recently focused on the discovery of new and safer remedies. Particularly, great interest has been attracted by oligomeric procyanidin bioactivity, able to promote hair epithelial cell growth as well as to induce the anagen phase. Specifically, the procyanidin B2, a dimeric derivative extracted from apples, has demonstrated to be one of the most effective and safest natural compounds in promoting hair growth, both in vitro and in humans by topical applications. By evaluating the polyphenolic content of different apple varieties, we have recently found in the apple fruits of cv Annurca (AFA), native to Southern Italy, one of the highest contents of oligomeric procyanidins, and, specifically, of procyanidin B2. Thus, in the present work we explored the in vitro bioactivity of AFA polyphenolic extract as a nutraceutical formulation, named AppleMets (AMS), highlighting its effects on the cellular keratin expression in a human experimental model of adult skin. Successively, testing the effects of AMS on hair growth and tropism in healthy subjects, we observed significant results in terms of increased hair growth, density, and keratin content, already after 2 months. This study proves for the first time the impact of apple procyanidin B2 on keratin biosynthesis in vitro, and highlights its effect as a nutraceutical on human hair growth and tropism.

Are you more concerned about or relieved by medicines? An explorative randomized study of the impact of telephone counseling by pharmacists on patients' beliefs regarding medicines and blood pressure control.

OBJECTIVES: The aim was to determine the impact of a telephone counseling service, provided bi-monthly by pharmacist, on patients' beliefs about antihypertensive medicines and blood pressure (BP) control. METHODS: Either hypertensive patients were randomly assigned to a control group (CG, usual care) or an intervention group (IG). All patients had BP values registered and filled in the Italian version of the Belief Medicine Questionnaire (BMQ). After 12 months, patients filled in the BMQ again and had their self-reported BP registered. The intervention consisted of an educational/counseling session based on patients' needs assessment provided bi-monthly by a pharmacist for one year via telephone. RESULTS: 80 CG and 84 IG patients were recruited. After 12 months, there were significant differences between IG and CG for both BMQ's Necessity and Concern score (p < 0.001; p < 0.001 respectively) and a significant reduction in BP values in IG (p < 0.001). CONCLUSIONS: The intervention improves BP control by modifying patients' perception about treatments and involving patients as participants in the management of their health. PRACTICE IMPLICATIONS: This paper could serve as a guideline for other studies to confirm the effectiveness of this intervention in modifying health behavior, and the role of hospital pharmacist.

A Healthy Balance of Plasma Cholesterol by a Novel Annurca Apple-Based Nutraceutical Formulation: Results of a Randomized Trial.

Cardiovascular diseases are nowadays preferential targets of preventive medicine through a straightforward therapy on lipid profile. However, statins, the first-line lipid-lowering drug therapy, specifically act on low-density lipoprotein cholesterol (LDL-C), having a modest effect on plasma high-density lipoprotein cholesterol (HDL-C) concentrations. Today, a number of novel HDL-targeted therapies are emerging, along with unexpected side effects. Thus, novel and possibly safe substances, able to correct impaired lipid profile in humans, are still in great demand. Herein, based on encouraging clinical data, we formulated a nutraceutical product (AppleMetS®, AMS), based on a polyphenolic extract from Annurca apple, and demonstrated that two capsules a day of AMS, after one month, have a LDL-C lowering outcome equivalent to 40 mg of simvastatin or 10 mg of atorvastatin. Nevertheless, different from statin-based therapy, AMS exerted a notable effect on HDL (+49.2%). Based on the trial results, we can assert that AMS formulation could effectively integrate the current therapeutic arsenal to correct impaired lipid profile in humans. Specifically, AMS may be considered a complementary and/or alternative safe substance suitable for the treatment of mildly hypercholesterolemic subjects who do not present occurrence of atheromatous plaques yet.

Annurca (Malus pumila Miller cv. Annurca) apple as a functional food for the contribution to a healthy balance of plasma cholesterol levels: results of a randomized clinical trial.

BACKGROUND: Recent human studies have evaluated the effect of daily apple consumption on plasma cholesterol level, which is recognized as an important risk factor for cardiovascular disease (CVD). Nevertheless, slightly significant effects have been generally registered although consuming more than two apples a day for several weeks. RESULTS: This study describes the influence of daily consumption of Annurca apples on the cholesterol levels of mildly hypercholesterolaemic healthy subjects. A monocentric, randomized, parallel-group, placebo-controlled, 4-month study was conducted. The subjects (n = 250) were randomly assigned to five treatment groups (each one of 50 subjects: 28 men and 22 women). Four groups were administered one apple per day among the following: Red Delicious, Granny Smith, Fuji, Golden Delicious. The fifth group was asked to consume two Annurca apples per day, since the weight of this cultivar is on average half that of the commercial ones considered in this study. Comparing results, Annurca led to the most significant outcome, allowing a reduction in total and low-density lipoprotein cholesterol levels by 8.3% and 14.5%, respectively, and an increase in high-density lipoprotein cholesterol levels by 15.2% (all P < 0.001). CONCLUSION: Our data would reasonably indicate Annurca apple as a useful tool to contribute to the prevention of CVD risk through normal diet. © 2016 Society of Chemical Industry.