Diabetes Type II in Correlation to Non-Cancer and Cancer Diseases in 49 WHO Selected Countries (SC) on The Base of Age Standardized Death Rate (ASDR)

n/

Long-Term Treatment of Overweight and Obesity with Polyglucosamine (PG L112): Randomized Study Compared with Placebo in Subjects after Caloric Restriction

BACKGROUND: Short-term treatment of overweight and obesity with polyglucosamine (PG) was found to be more effective than placebo and orlistat in double-blind clinical studies. OBJECTIVE: The aim of the study was to compare the efficacy of long-term (12-mo) treatment of weight loss with PG and placebo (PL). METHODS: This was a double-blind randomized study in 100 participants of both sexes with a body mass index (in kg/m2) >30 to <35. One group of 50 participants was treated for 1 y with PG at 1.6 g/d and a similar group received PL. PG is a combination of low-molecular-weight chitosan with organic acids. Participants were instructed to reduce their caloric intake by 10% and increase the physical activity level by 9 metabolic equivalent task hours/wk. Dietary compliance was checked every 3 mo by using a weekly questionnaire [food intake assessment (FIA)] based on 25 different food servings. Body weight (BW), waist circumference (WC), blood pressure (BP), glucose, lipids, and high-sensitivity C-reactive protein (hs-CRP) were also monitored. RESULTS: Ninety-seven participants completed the study (49 in the PG group, 48 in the PL group). The decrease in calories was similar in both groups, as was the change in number of food servings (P > 0.05, ANOVA). Decreases in BW and WC were 8.0 kg and 10.2 cm, respectively, in the PL group, whereas they were 12.1 kg and 13.3 cm in the PG group (P < 0.001, ANOVA). The decrease in BP, plasma lipids, glucose, and hs-CRP was more evident in the group treated with PG (P < 0.05, ANOVA). The intake of lipids was found to correlate directly with hs-CRP, with the exception of extra-virgin olive oil. CONCLUSIONS: PG was found to be more effective than PL in reducing BW, WC, glucose, BP, plasma lipids, and hs-CRP in moderately obese individuals undergoing a 10% caloric reduction and a slight increase in physical activity. Dietary monitoring with the use of an FIA was an effective tool in supporting dietary compliance. This trial was registered at clinicaltrials.gov as U111111292405 (WHO)

Efficacy and safety of Meriva\uae, a curcumin-phosphatidylcholine complex, during extended administration in osteoarthritis patients

In a previous three-month study of Meriva, a proprietary curcumin-phosphatidylcholine phytosome complex, decreased joint pain and improvement in joint function were observed in 50 osteoarthritis (OA) patients. Since OA is a chronic condition requiring prolonged treatment, the long-term efficacy and safety of Meriva were investigated in a longer (eight months) study involving 100 OA patients. The clinical end points (Western Ontario and McMaster Universities [WOMAC] score, Karnofsky Performance Scale Index, and treadmill walking performance) were complemented by the evaluation of a series of inflammatory markers (interleukin [IL]-1beta, IL-6, soluble CD40 ligand [sCD40L], soluble vascular cell adhesion molecule (sVCAM)-1, and erythrocyte sedimentation rate [ESR]). This represents the most ambitious attempt, to date, to evaluate the clinical efficacy and safety of curcumin as an anti-inflammatory agent. Significant improvements of both the clinical and biochemical end points were observed for Meriva compared to the control group. This, coupled with an excellent tolerability, suggests that Meriva is worth considering for the long-term complementary management of osteoarthritis

Artificial Saliva in Diabetic Xerostomia (ASDIX): Double Blind Trial of Aldiamed® Versus Placebo

Xerostomia is a symptom frequently present in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM). In the present trial, the activity of an artificial saliva (aldiamed® spray) in comparison to a placebo spray were used to evaluate the xerostomia and the saliva antioxidant capacity (SAT). Sixty patients of both genders with T1DM or T2DM were randomized into two groups of 30 subjects each. The experiment was a double-blind study approved by the Ethics Committee of the “G. d’Annunzio University” of Chieti and Pescara. Moreover, measurements of the stimulated saliva flow rate and the ultrasonography of the submandibular and parotid glands were performed at both the study time points. The results demonstrated statistically significant differences between the treatments in terms of the xerostomia average score. Specifically, the values were at baseline and after 30 days 2.9 ± 1.31 and 3.0 ± 1.44 and 1.4 ± 1.48 and 2.4 ± 0.99 for aldiamed® spray and the placebo, respectively. Meanwhile, no statistically significant differences were shown between the two groups for the other variables, such as the salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands

Reduction of delayed onset muscle soreness by a novel curcumin delivery system (Meriva\uc2\uae): A randomised, placebo-controlled trial

BACKGROUND: Delayed onset muscle soreness (DOMS) due to eccentric muscle activity is associated with inflammatory responses and production of reactive oxygen species (ROS) that sustain both inflammation and oxidative stress. Curcumin, a powerful promoter of anti-oxidant response, is one of the best-investigated natural products, and is now commercially available as a lecithin delivery system (Meriva®, Indena SpA, Milan) with improved bio-availability. The aim of this study was to test whether curcumin could attenuate damage from oxidative stress and inflammation related to acute muscle injury induced by eccentric continuous exercise METHODS: This was a randomised, placebo-controlled, single-blind pilot trial. Twenty male healthy, moderately active volunteers were randomised to curcumin given as the Phytosome® delivery system 1 g twice daily (200 mg curcumin b.i.d.) or matching placebo. Supplementation was initiated 48 hours prior to a downhill running test and was continued for 24 hours after the test (4 days in total). Muscle damage was quantified by magnetic resonance imaging, laboratory tests and histological analyses on muscle samples obtained 48 hours after the test. Patient-reported pain intensity was also recorded. RESULTS: Subjects in the curcumin group reported less pain in the lower limb as compared with subjects in the placebo group, although significant differences were observed only for the right and left anterior thighs. Significantly fewer subjects in the curcumin group had MRI evidence of muscle injury in the posterior or medial compartment of both thighs. Increases in markers of muscle damage and inflammation tended to be lower in the curcumin group, but significant differences were only observed for interleukin-8 at 2 h after exercise. No differences in markers of oxidative stress and muscle histology were observed CONCLUSIONS: Curcumin has the potential for preventing DOMS, as suggested by its effects on pain intensity and muscle injury. Larger studies are needed to confirm these results and further clarify the mechanism of action of curcumin

Current Experience in Testing Mitochondrial Nutrients in Disorders Featuring Oxidative Stress and Mitochondrial Dysfunction: Rational Design of Chemoprevention Trials

An extensive number of pathologies are associated with mitochondrial dysfunction (MDF) and oxidative stress (OS). Thus, mitochondrial cofactors termed “mitochondrial nutrients” (MN), such as α-lipoic acid (ALA), Coenzyme Q10 (CoQ10), and l-carnitine (CARN) (or its derivatives) have been tested in a number of clinical trials, and this review is focused on the use of MN-based clinical trials. The papers reporting on MN-based clinical trials were retrieved in MedLine up to July 2014, and evaluated for the following endpoints: (a) treated diseases; (b) dosages, number of enrolled patients and duration of treatment; (c) trial success for each MN or MN combinations as reported by authors. The reports satisfying the above endpoints included total numbers of trials and frequencies of randomized, controlled studies, i.e., 81 trials testing ALA, 107 reports testing CoQ10, and 74 reports testing CARN, while only 7 reports were retrieved testing double MN associations, while no report was found testing a triple MN combination. A total of 28 reports tested MN associations with “classical” antioxidants, such as antioxidant nutrients or drugs. Combinations of MN showed better outcomes than individual MN, suggesting forthcoming clinical studies. The criteria in study design and monitoring MN-based clinical trials are discussed