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Treatment of brittle nail with a hydroxypropyl chitosan-based lacquer, alone or in combination with oral biotin: A randomized, assessor-blinded trial.
Chiavetta, A, Mazzurco, S, Secolo, MP, Tomarchio, G, Milani, M
Dermatologic therapy. 2019;(5):e13028
Abstract
We evaluated in a randomized, assessor-blinded, study the efficacy of a hydroxypropyl chitosan-based nail lacquer (HPC-NL) alone or in combination with oral biotin (HPC-NL + B) in the treatment of brittle nail syndrome (BNS). Fifty subjects (21 men; mean age 64 years) with BNS were enrolled. Twenty-six were randomly assigned to HPC-NL and 24 to the HPC-NL and biotin, 10 mg/daily (+B). Topical and oral treatments lasted for 4 consecutive months. The primary outcome was the evolution of the Onychodystrophy Global Severity Score (OGSS) assessing nail dystrophy, lamellar and longitudinal splitting, dyschromia, and pitting. At baseline, the OGSS, mean (SD), was 8.4 (2.1) in the HPC-NL group and 11.8 (2.3) in the HPC-NL + B group. The OGSS was significantly reduced during treatments in both groups. At Month 4, OGSS was reduced by 57% (HPC-NL) and 62% (HPC-NL + B). At the end of study period, the percentage of subjects with an OGSS reduction of ≥50% in comparison with baseline was 53% in the HPC-NL group and 80% in the HPC-NL + B group (p = .05). Both treatments were well tolerated. In subjects with BNS, HPC-NL alone is associated with a clinically relevant improvement of nail appearance. The combination of HPC-NL and oral biotin is associated with further clinical improvement.
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Effects of a New Nutraceutical Formulation (Berberine, Red Yeast Rice and Chitosan) on Non-HDL Cholesterol Levels in Individuals with Dyslipidemia: Results from a Randomized, Double Blind, Placebo-Controlled Study.
Spigoni, V, Aldigeri, R, Antonini, M, Micheli, MM, Fantuzzi, F, Fratter, A, Pellizzato, M, Derlindati, E, Zavaroni, I, Bonadonna, RC, et al
International journal of molecular sciences. 2017;(7)
Abstract
Increased non high-density lipoprotein (HDL)/low-density lipoprotein (LDL) cholesterol levels are independent risk factors for cardiovascular (CV) mortality with no documented threshold. A new combination of nutraceuticals (berberine 200 mg, monacolin K 3 mg, chitosan 10 mg and coenzyme Q 10 mg) with additive lipid-lowering properties has become available. The aim of the study is to test the efficacy of the nutraceutical formulation (one daily) in lowering non-HDL cholesterol vs. placebo at 12 weeks in individuals with non-HDL-cholesterol levels ≥160 mg/dL. 39 subjects (age 52 ± 11 years; 54% females; body mass index 27 ± 4 kg/m²) were randomized (3:1) in a double blind phase II placebo-controlled study. At baseline, 4 and 12 weeks main clinical/biohumoral parameters, pro-inflammatory cytokines, (gut)-hormones, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels and endothelial progenitor cell (EPC) number were assessed. Baseline characteristics were comparable in the two groups. The intervention significantly decreased non-HDL cholesterol (-30 ± 20 mg/dL; p = 0.012), LDL cholesterol (-31 ± 18 mg/dL, p = 0.011) and apolipoprotein (Apo) B (-14 ± 12 mg/dL, p = 0.030) levels compared to the placebo. Pro-inflammatory, hormonal, PCSK9 and EPC levels remained stable throughout the study in both groups. The intervention was well tolerated. Three adverse events occurred: Epstein Barr virus infection, duodenitis and asymptomatic but significant increase in creatine phosphokinase (following intense physical exercise) which required hospitalization. The tested nutraceutical formulation may represent a possible therapeutic strategy in dyslipidemic individuals in primary prevention.
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Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial.
Akizawa, T, Tsuruta, Y, Okada, Y, Miyauchi, Y, Suda, A, Kasahara, H, Sasaki, N, Maeda, Y, Suzuki, T, Matsui, N, et al
BMC nephrology. 2014;:98
Abstract
BACKGROUND HS219 (40 mg chitosan-loaded chewing gum) is designed to bind salivary phosphorus as an add-on to available phosphorus binders. We performed a randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of HS219 in hemodialysis (HD) patients with hyperphosphatemia as an add-on to phosphorus binders. METHODS Sixty-eight HD patients who were maintained on calcium carbonate (n=33) or sevelamer hydrochloride (n=35) were enrolled. The primary end point was a change in serum phosphorus levels. Secondary end points included changes in levels of salivary phosphorus, serum calcium, parathyroid hormone (PTH), and intact fibroblast growth factor (iFGF) 23. RESULTS Sixty-three patients chewed either HS219 (n=35) or placebo (n=28) for 30 min, three times a day, for 3 weeks. HS219 was well tolerated and safe. However, HS219 was not superior to placebo with additional reduction of serum phosphorus with respect to phosphorus binders at the end of the chewing period. There were no significant effects of HS219 on reduction of salivary phosphorus, serum calcium, iPTH, or iFGF23 levels. CONCLUSIONS The chitosan-loaded chewing gum HS219 does not affect serum and salivary phosphorus levels in Japanese HD patients with hyperphosphatemia. Our findings do not support previous findings that 20 mg of chitosan-loaded chewing gum reduces serum and salivary phosphorus levels. TRIAL REGISTRATION [corrected] ClinicalTrials.gov NCT01039428, 24 December, 2009.
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Effect of salivary phosphate-binding chewing gum on serum phosphate in chronic kidney disease.
Block, GA, Persky, MS, Shamblin, BM, Baltazar, MF, Singh, B, Sharma, A, Pergola, P, Smits, G, Comelli, MC
Nephron. Clinical practice. 2013;(1-2):93-101
Abstract
BACKGROUND/AIMS: Serum phosphate (P) has been linked to adverse events in patients with chronic kidney disease. Salivary phosphate (Psal) has been proposed as a potential target of therapy with a chitosan-containing chewing gum. METHODS We conducted several pilot studies to characterize Psal and its relationship with kidney function and subsequently conducted two clinical efficacy studies: a double-blind placebo-controlled trial in patients with end-stage renal disease (ESRD) and an open-label trial in those with stage 3-4 CKD. RESULTS Pilot studies demonstrated no relationship between the level of kidney function and Psal. Mean Psal was approximately 6.46 mmol/l across the entire spectrum of kidney function. Passive saliva collection demonstrated higher Psal concentration as compared to active collection. There was no evidence of diurnal variation in Psal. Twice daily 20 mg chitosan gum over 4 weeks reduced serum P by 0.065 mmol/l in the double-blind, placebo-controlled trial in ESRD (p = NS vs. placebo). In an open-label extension in these subjects, 40 mg chitosan gum three times daily reduced serum P by 0.065 mmol/l (p = 0.03 vs. end of washout). In a 2-week open-label trial in patients with CKD not on dialysis, 20 mg chitosan gum given three times daily reduced serum P by 0.05 mmol/l (p = 0.003 vs. day 1). Neither trial demonstrated any significant change in Psal with chitosan gum. CONCLUSIONS Psal concentration is approximately 4-5 times that of serum P and is not related to glomerular filtration rate. Chitosan chewing gum resulted in a reduction of serum P by approximately 0.05-0.065 mmol/l but had no effect on Psal concentration.
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Chitosan-containing gum chewing accelerates antibacterial effect with an increase in salivary secretion.
Hayashi, Y, Ohara, N, Ganno, T, Ishizaki, H, Yanagiguchi, K
Journal of dentistry. 2007;(11):871-4
Abstract
OBJECTIVES This study was designed to confirm the mechanical efficacy of chewing chitosan-containing gum to suppress the growth of oral bacteria compared to a mouth rinse, and to demonstrate the increased salivary secretion due to chewing chitosan-containing gum. METHOD Twelve healthy subjects were recruited from among the staff and students of Nagasaki University School of Dentistry. For the slab of gum study, the subjects chewed chitosan-containing gum for 5 min and then rested for 5 min. For the testing of the chitosan mouth rinse solution, the subjects gargled 10 mL of solution for 30s followed by resting for 9 min 30s. These protocols were continuously repeated five times for 50 min on the same day. For the salivary secretion experiment, the gum chewing was repeated three times per day for 2 days. RESULTS The amount of oral bacteria in the subjects who chewed chitosan-containing gum significantly decreased during all three sampling times except at 60 min for total bacteria in comparison to those in the rinse group. Chitosan-containing gum chewing also significantly increased the secretion of saliva. CONCLUSIONS Chitosan-containing gum chewing has a greater antibacterial effect and it also increases salivary secretion. The present findings strongly indicate that the application of natural materials such as chitosan is useful for both oral health and the quality of life.
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Evaluating efficacy of a chitosan product using a double-blinded, placebo-controlled protocol.
Kaats, GR, Michalek, JE, Preuss, HG
Journal of the American College of Nutrition. 2006;(5):389-94
Abstract
OBJECTIVE To examine the safety and efficacy of a chitosan dietary supplement on body composition under free-living conditions. DESIGN In a randomized, double-blinded, placebo-controlled dietary intervention protocol, subjects were assigned to a treatment group (TRT), a placebo group (PLA) and a control group (CTL). SUBJECTS A total of 150 overweight adults enrolled; 134 (89.3%) completed the study; 111 (82.8%) were women who were similarly distributed in the three groups. INTERVENTION The TRT group took six 500 mg chitosan capsules per day and both TRT and PLA groups wore pedometers during their waking hours and recorded daily step totals. The CTL group followed weight loss programs of their choice, and took the same baseline and ending tests. MEASURES OF OUTCOME Outcome measures were Dual Energy X-ray Absorptiometry tests, fasting blood chemistries, and self-reported daily activity levels and caloric intakes. RESULTS Compared to CTL, the TRT group lost more weight (-2.8 lbs vs. +0.8 lbs, p < 0.001) and fat mass (-2.6 lbs vs. +0.1 lbs, p = 0.006). Compared to PLA, the TRT group lost more weight (-2.8 lbs. vs. -0.6 lbs, p = 0.03), % fat (-0.8% vs. +0.4%, p = 0.003), fat mass (-2.6 lbs vs. +0.6 lbs, p = 0.001) and had a greater body composition improvement index (BCI) (+2.4 lbs vs. -1.9 lbs, p = 0.002). CONCLUSIONS These data provide evidence for the efficacy of a chitosan compound to facilitate the depletion of excess body fat under free-living conditions with minimal loss of fat-free or lean body mass.
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Microcrystalline chitosan is ineffective to decrease plasma lipids in both apolipoprotein E epsilon 4 carriers and non-carriers: a long-term placebo-controlled trial in hypercholesterolaemic volunteers.
Lehtimäki, T, Metso, S, Ylitalo, R, Rontu, R, Nikkilä, M, Wuolijoki, E, Ylitalo, P
Basic & clinical pharmacology & toxicology. 2005;(2):98-103
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Abstract
Chitosan is a deacetylated product of chitin. Microcrystalline form of chitosan has a large adsorption area claimed to decrease gastrointestinal absorption of cholesterol. However, the long-term effect of chitosan on plasma lipids is variable, the averaged influence being negligible or lacking in mildly-to-moderately hypercholesterolaemic (4.8-6.8 mmol/l) subjects. We evaluated whether this variation and inefficacy depend on apolipoprotein E genotype. 130 middle-aged, otherwise healthy men (n=55) and women (n=75) were randomized into two treatment groups for a 7 month trial. During a 1 month run-in period all participants received placebo. Subsequently, one half first took placebo twice daily for 3 months and then 1.2 g chitosan twice daily for 3 months, and the other half vice versa in a cross-over way. Altogether 84 participants completed the study. Plasma lipids and glucose were determined at the end of each phase of the study, and all subjects undergone to the cross-over phases were apolipoprotein E genotyped. Chitosan altered plasma total, low- and high density cholesterol, triglycerides, and blood glucose in neither apolipoprotein E epsilon 4 allele carriers (n=29) nor non-carriers (n=55), compared to placebo. In conclusions, chitosan is ineffective to decrease plasma lipids in apolipoprotein E epsilon 4 carrier and non-carrier phenotypes with mildly-to-moderately increased plasma cholesterol.