Efficacy and Tolerability of a Food Supplement Based on Zea mays L., Gymnema sylvestre (Retz.) R.br.ex Sm, Zinc and Chromium for the Maintenance of Normal Carbohydrate Metabolism: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

A study on 81 individuals (18-75 years old) with mildly impaired fasting blood glucose (FBG) concentrations (98-125 mg/dL) was undertaken to investigate the tolerability of a food supplement (FS) based on Zea mays and Gymnema sylvestre extracts, zinc, and chromium and its efficacy on glucose and lipid metabolism. The subjects were randomized into three groups (27 in each group) and supplemented with one or two tablet(s)/day of FS (groups 1 and 2, respectively), or two tablets/day of placebo (group 3). Blood sampling was carried out at baseline (t0) and after a 3-month treatment (t1), and biochemical parameters associated with glucose and lipid metabolism and kidney and liver toxicity were evaluated. Compared to the placebo, FBG and glycated haemoglobin (HbA1c) were significantly (p < 0.001) reduced in group 1 subjects. In contrast, at the doses of one and two tablet(s)/day, the FS exerted no effect on the other parameters examined. We conclude that in subjects with slightly impaired FBG, ingestion of a FS based on Z. mays and G. sylvestre extracts, zinc, and chromium over 3 months lowers FBG and modulates glucose homeostasis by improving glucose metabolism. These beneficial effects occur in the absence of biochemical evidence of kidney and liver toxicity.

Efficacy of a food supplement based on S-adenosyl methionine and probiotic strains in subjects with subthreshold depression and mild-to-moderate depression: A monocentric, randomized, cross-over, double-blind, placebo-controlled clinical trial.

Depression is one of the most serious chronic psychiatric disorders affecting people worldwide. Subthreshold depression (SD) is a form of subclinical depression with increased risk of major depressive disorder (MDD). Patients diagnosed with SD may not be eligible for antidepressant drugs and, particularly in the case of MDD, these antidepressants may have adverse effects which outweigh their therapeutic effects, leading to discontinuation of therapy. Food supplements could provide an alternative strategy. The aim of this study is to demonstrate the efficacy of a food supplement based on a combination of S-adenosyl methionine (SAMe, 200 mg/day) and probiotics (Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175, 3 ×109 CFU/day) in reducing depression symptoms in a monocentric, randomised, double-blind, placebo-controlled, cross-over clinical trial. 80 Subjects were recruited and offered the food supplement or placebo daily for three months, according to a cross-over clinical trial design, followed by a six-week follow-up period. The efficacy of the food supplement was measured by means of the "Hamilton Depression Rating Scale" (HAM-D) and "Patient Health Questionnaire-9" (PHQ-9), using a mixed analysis of variance model, with random intercept, for statistical analysis. The food supplement showed a significant decrease of PHQ-9 and HAM-D scores resulting in reduced SD and MDD symptoms as compared to placebo. In conclusion, the daily intake of the food supplement based on SAMe and probiotic strains for a period of three months is effective in improving the quality of life of SD subjects who are not eligible for antidepressant therapies, and patients suffering from mild-to-moderate depression who are not sensitive or cannot tolerate conventional drugs.

The COPD Italian Lung Information Needs Questionnaire (LINQ): development, preliminary validation, and findings.

Chronic obstructive pulmonary disease (COPD) patients have poor knowledge about the disease. Until now, it has not been possible to check the information needs of these patients. The Lung Information Needs Questionnaire (LINQ), however, could fill this particular need. The aims of this study were to identify patient perceptions about COPD, and what information patients need, and to verify whether the questionnaire is comprehensible. Data demonstrate that LINQ is easily understood: 82% answered all questions with "I have properly understood the question". LINQ is quick to apply (approx. 6 min to complete). Sixty-seven per cent of patients had incorrect knowledge about their prognosis. Thirty-six per cent did not know when to call an ambulance. Eight per cent of smokers said that no one had ever told them to stop smoking. Compliance with therapy results was not sufficient. Patients had poor knowledge of the causes of COPD, and they knew little about the whys and wherefores of COPD treatment. LINQ represents a valid means of investigating patients afflicted with COPD and managing pathology control by the doctor and by the patient. LINQ represents a fundamental means of investigating otherwise-unknown COPD issues.