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1.
A Dunaliella salina Extract Counteracts Skin Aging under Intense Solar Irradiation Thanks to Its Antiglycation and Anti-Inflammatory Properties.
Havas, F, Krispin, S, Cohen, M, Loing, E, Farge, M, Suere, T, Attia-Vigneau, J
Marine drugs. 2022;(2)
Abstract
Glycation, and the resulting buildup of advanced glycation end products (AGEs), is recognized as a key driver of cumulative skin damage and skin aging. Dunaliella salina is a halophile microalga adapted to intense solar radiation through the production of carotenoids. We present a natural supercritical CO2 extract of Dunaliella salina rich in the colorless carotenoids phytoene and phytofluene. The extract exhibited antiglycation and anti-inflammatory activities in ex vivo testing, showing strongly reduced formation of N-ε-carboxy-methyl-lysine with exposure to methylglyoxal, reduced AGE receptor levels, and significantly reduced interleukins 6 and 8. In a placebo-controlled clinical study under intense solar exposure, the extract significantly reduced the skin's glycation scores and its sensitivity to histamine; key skin aging parameters were also significantly improved vs. placebo, including wrinkle counts and spots. These results demonstrate the value of this Dunaliella salina extract, rich in colorless carotenoids, as an antiglycative, anti-inflammatory, and antiaging active ingredient, including in high-irradiation contexts.
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2.
Biologic Treatment in Combination with Lifestyle Intervention in Moderate to Severe Plaque Psoriasis and Concomitant Metabolic Syndrome: Rationale and Methodology of the METABOLyx Randomized Controlled Clinical Trial.
Pinter, A, Schwarz, P, Gerdes, S, Simon, JC, Saalbach, A, Rush, J, Melzer, N, Kramps, T, Häberle, B, Reinhardt, M
Nutrients. 2021;(9)
Abstract
Inflammatory diseases including psoriasis are associated with metabolic and cardiovascular comorbidities, including obesity and metabolic syndrome. Obesity is associated with greater psoriasis disease severity and reduced response to treatment. Therefore, targeting metabolic comorbidities could improve patients' health status and psoriasis-specific outcomes. METABOLyx is a randomized controlled trial evaluating the combination of a lifestyle intervention program with secukinumab treatment in psoriasis. Here, the rationale, methodology and baseline patient characteristics of METABOLyx are presented. A total of 768 patients with concomitant moderate to severe plaque psoriasis and metabolic syndrome were randomized to secukinumab 300 mg, or secukinumab 300 mg plus a tailored lifestyle intervention program, over 24 weeks. A substudy of immunologic and metabolic biomarkers is ongoing. The primary endpoint of METABOLyx is PASI90 response at week 24. Other endpoints include patient-reported outcomes and safety. METABOLyx represents the first large scale clinical trial of an immunomodulatory biologic in combination with a standardized lifestyle intervention.
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3.
Interactions of Oxysterols with Atherosclerosis Biomarkers in Subjects with Moderate Hypercholesterolemia and Effects of a Nutraceutical Combination (Bifidobacterium longum BB536, Red Yeast Rice Extract) (Randomized, Double-Blind, Placebo-Controlled Study).
Cicolari, S, Pavanello, C, Olmastroni, E, Puppo, MD, Bertolotti, M, Mombelli, G, Catapano, AL, Calabresi, L, Magni, P
Nutrients. 2021;(2)
Abstract
BACKGROUND Oxysterol relationship with cardiovascular (CV) risk factors is poorly explored, especially in moderately hypercholesterolaemic subjects. Moreover, the impact of nutraceuticals controlling hypercholesterolaemia on plasma levels of 24-, 25- and 27-hydroxycholesterol (24-OHC, 25-OHC, 27-OHC) is unknown. METHODS Subjects (n = 33; 18-70 years) with moderate hypercholesterolaemia (low-density lipoprotein cholesterol (LDL-C:): 130-200 mg/dL), in primary CV prevention as well as low CV risk were studied cross-sectionally. Moreover, they were evaluated after treatment with a nutraceutical combination (Bifidobacterium longum BB536, red yeast rice extract (10 mg/dose monacolin K)), following a double-blind, randomized, placebo-controlled design. We evaluated 24-OHC, 25-OHC and 27-OHC levels by gas chromatography/mass spectrometry analysis. RESULTS 24-OHC and 25-OHC were significantly correlated, 24-OHC was correlated with apoB. 27-OHC and 27-OHC/total cholesterol (TC) were higher in men (median 209 ng/mL and 77 ng/mg, respectively) vs. women (median 168 ng/mL and 56 ng/mg, respectively); 27-OHC/TC was significantly correlated with abdominal circumference, visceral fat and, negatively, with high-density lipoprotein cholesterol (HDL-C). Triglycerides were significantly correlated with 24-OHC, 25-OHC and 27-OHC and with 24-OHC/TC and 25-OHC/TC. After intervention, 27-OHC levels were significantly reduced by 10.4% in the nutraceutical group Levels of 24-OHC, 24-OHC/TC, 25-OHC, 25-OHC/TC and 27-OHC/TC were unchanged. CONCLUSIONS In this study, conducted in moderate hypercholesterolemic subjects, we observed novel relationships between 24-OHC, 25-OHC and 27-OHC and CV risk biomarkers. In addition, no adverse changes of OHC levels upon nutraceutical treatment were found.
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Efficacy and tolerability of a nutraceutical combination of red yeast rice, guggulipid, and chromium picolinate evaluated in a randomized, placebo-controlled, double-blind study.
Iskandar, I, Harahap, Y, Wijayanti, TR, Sandra, M, Prasaja, B, Cahyaningsih, P
Complementary therapies in medicine. 2020;:102282
Abstract
Hypercholesterolemia is the major risk factor in the development of coronary heart disease. Coronary heart disease is a leading cause of morbidity and mortality in many countries worldwide. An increasing attention is now paid to nutraceuticals development for prevention and cure of dyslipidemia, especially for patients who do not wish to use chemical statins. The cholesterol lowering effect and the tolerability of NutraforChol®, a nutraceutical product containing red yeast rice extract, guggulipid extract and chromium picolinate, was evaluated on subjects who had total cholesterol level 200-239 mg/dL and LDL cholesterol level 100-159 mg/dL. In this study, a randomized, placebo-controlled, double-blind study which consisted of 4 weeks run-in period and 8 weeks treatment period was performed. Based on the study results, NutraforChol® effectively decreased total cholesterol (-15.9 %) and LDL level (-19.9 %) after two weeks consumption. The total cholesterol and LDL reduction were maintained during 8 weeks study period. At study termination (week 8), there was a significant difference between total cholesterol level of NutraforChol® treated group (173.5 ± 21.7 mg/dL) and placebo-treated group (204.5 ± 22.8 mg/dL) (p < 0.05). In addition, there was a significant difference between LDL level at week 8 in NutraforChol® group (115.5 ± 22.2 mg/dL) and placebo-treated group (145.1 ± 23.7 mg/dL) (p < 0.05). The tolerability of NutraforChol® was also evaluated. There were no significant changes (p > 0.05) on renal and liver function parameters between baseline and study termination. Thus, NutraforChol® may be considered as a complementary or alternative safe nutraceuticals for the treatment of mild dyslipidemic subjects.
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The Effects of Fermented Laminaria japonica on Short-Term Working Memory and Physical Fitness in the Elderly.
Reid, SNS, Ryu, JK, Kim, Y, Jeon, BH
Evidence-based complementary and alternative medicine : eCAM. 2018;:8109621
Abstract
Considering the neuroprotective and antioxidant potential of fermented Laminaria japonica A. (FST), the purpose of the present study is to establish whether FST may be considered a viable, efficacious supplement that can be administered in later life to offset neurodegenerative conditions associated with aging. Forty senior subjects participated in a randomized, double-blind, and placebo-controlled study. Two groups were formed, one FST group (n = 32, 72.35 ± 5.54 yrs) and one placebo (CON) (n = 28, 74.57 ± 5.69 yrs), which received 1.5 g/day of FST for 6 weeks. Subjects were asked to abstain from any regular exercise. In order to analyze short-term memory, a variety of neuropsychological tests were implemented. Body composition, physical fitness evaluations, antioxidant function, and inflammatory markers were also included in the analyses pre- and posttest. We demonstrated that FST significantly improved neuropsychological test scores, including higher scores in the K-MMSE, numerical memory test, Raven test, and iconic memory, compared to the CON group. Shorter test trial times in the 6-meter [corrected] walk test were observed in the FST group (p<0.001 and p<0.05, trials 1 and 2, respectively). FST also significantly increased antioxidant activity of GPx, GSR, and SOD, reduced the production of TBARS, and lowered 8-oxoDG levels. The present study highlights the potential widespread application of FST in protecting against the degenerative effects of aging on short-term memory and physical function. Neuropsychological evaluation indicates that FST may provide a protective mechanism against cognitive impairment associated with dementia. Neuromuscular integrity and physical function are typically compromised in aging and dementia patients; thus, whether by stimulation of muscle-related growth factors or an increase in serum BDNF, FST supplementation may act to preserve physical function in the elderly. The bioactive constituents of FST such as GABA and fucoidan acting to provide improvements in antioxidant activity following FST supplementation may protect against progressive degeneration purportedly caused by reactive oxygen species.
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Beetroot juice ingestion during prolonged moderate-intensity exercise attenuates progressive rise in O2 uptake.
Tan, R, Wylie, LJ, Thompson, C, Blackwell, JR, Bailey, SJ, Vanhatalo, A, Jones, AM
Journal of applied physiology (Bethesda, Md. : 1985). 2018;(5):1254-1263
Abstract
Nitrate-rich beetroot juice (BR) supplementation has been shown to increase biomarkers of nitric oxide availability with implications for the physiological responses to exercise. We hypothesized that BR supplementation before and during prolonged moderate-intensity exercise would maintain an elevated plasma nitrite concentration ([[Formula: see text]]), attenuate the expected progressive increase in V̇o2 over time, and improve performance in a subsequent time trial (TT). In a double-blind, randomized, crossover design, 12 men completed 2 h of moderate-intensity cycle exercise followed by a 100-kJ TT in three conditions: 1) BR before and 1 h into exercise (BR + BR); 2) BR before and placebo (PL) 1 h into exercise (BR + PL); and 3) PL before and 1 h into exercise (PL + PL). During the 2-h moderate-intensity exercise bout, plasma [[Formula: see text]] declined by ~17% in BR + PL but increased by ~8% in BR + BR such that, at 2 h, plasma [[Formula: see text]] was greater in BR + BR than both BR + PL and PL + PL ( P < 0.05). V̇o2 was not different among conditions over the first 90 min of exercise but was lower at 120 min in BR + BR (1.73 ± 0.24 l/min) compared with BR + PL (1.80 ± 0.21 l/min; P = 0.08) and PL + PL (1.83 ± 0.27 l/min; P < 0.01). The decline in muscle glycogen concentration over the 2-h exercise bout was attenuated in BR + BR (~28% decline) compared with BR + PL (~44% decline) and PL + PL (~44% decline; n = 9, P < 0.05). TT performance was not different among conditions ( P > 0.05). BR supplementation before and during prolonged moderate-intensity exercise attenuated the progressive rise in V̇o2 over time and appeared to reduce muscle glycogen depletion but did not enhance subsequent TT performance. NEW & NOTEWORTHY We show for the first time that ingestion of nitrate during exercise preserves elevated plasma [nitrite] and negates the progressive rise in O2 uptake during prolonged moderate-intensity exercise.
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Spirulina platensis effectively ameliorates anthropometric measurements and obesity-related metabolic disorders in obese or overweight healthy individuals: A randomized controlled trial.
Yousefi, R, Mottaghi, A, Saidpour, A
Complementary therapies in medicine. 2018;:106-112
Abstract
AIMS: Novel alternative treatments such as food supplements may be an effective approach to weight management. The aim of the present study was to investigate the possible effects of Spirulina Platensis (SP) on anthropometric measures, appetite and metabolic parameters in obese or overweight individuals. MATERIAL AND METHODS A total of fifty-two obese and overweight subjects (25 kg/m2 ≤ body mass index (BMI) <40 kg/m2) were randomly selected to be allocated to SP (4 × 500 mg daily tablets along with restricted calorie diet (RCD)) or placebo (placebo tablets along with RCD) for 12 weeks of intervention. Anthropometric measurements and appetite score were assessed at baseline, weeks 6 and 12. Biochemical assessments were performed at baseline and week 12. RESULTS Thirty-eight participants completed the intervention. Body weight, waist circumference, body fat and BMI significantly reduced in the SP group compared to the placebo group (p < 0.001, p = 0.049, p = 0.049 and p = 0.02, respectively). In the SP group, the reduction triglycerides (TG) and high sensitivity C-reactive protein levels was considerably significant compared to the placebo group (p = 0.03, p = 0.02, respectively). Appetite score was significantly reduced in the SP group compared to the baseline (p < 0.001). CONCLUSIONS This study suggests that spirulina platensis, as a complementary therapy may have beneficial effects on adherence to RCD, management of weight loss and also reduction in TG levels through possible modulatory effects on anti-inflammatory pathways.
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Short-Term Effects of a Combined Nutraceutical on Lipid Level, Fatty Liver Biomarkers, Hemodynamic Parameters, and Estimated Cardiovascular Disease Risk: A Double-Blind, Placebo-Controlled Randomized Clinical Trial.
Cicero, AFG, Fogacci, F, Bove, M, Veronesi, M, Rizzo, M, Giovannini, M, Borghi, C
Advances in therapy. 2017;(8):1966-1975
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Abstract
INTRODUCTION There is a growing interest in nutraceuticals improving cardiovascular risk factor levels and related organ damage. METHODS This double-blind, placebo-controlled randomized clinical trial aims to compare the effect of a combined nutraceutical containing red yeast rice (10 mg), phytosterols (800 mg), and L-tyrosol (5 mg) on lipid profile, blood pressure, endothelial function, and arterial stiffness in a group of 60 patients with polygenic hypercholesterolemia resistant to Mediterranean diet. RESULTS After 8 weeks of treatment, when compared to the placebo group, the active treated patients experienced a more favorable percentage change in total cholesterol (-16.3% vs 9.9%, P < 0.001 always), LDL-C (-23.4% vs -13.2%, P < 0.001 always), and hepatic steatosis index (-2.8%, P < 0.01 vs -1.8%, P < 0.05). Moreover, ALT (-27.7%, P < 0.001), AST (-13.8%, P = 0.004), and serum uric acid (-12.3%, P = 0.005) were reduced by the tested nutraceutical compound both compared to randomization and to placebo, which did not affect these parameters (P < 0.01 for all). Regarding the hemodynamic parameters, there was a decrease of systolic blood pressure (-5.6%) with the active treatment not observed with placebo (P < 0.05 vs baseline and placebo) and endothelial reactivity improved, too (-13.2%, P < 0.001 vs baseline). Consequently, the estimated 10-year cardiovascular risk score improved by 1.19% (SE 0.4%) (P = 0.01) in the nutraceutical-treated patients. CONCLUSION The tested nutraceutical association is able to improve the positive effects of a Mediterranean diet on a large number of CV risk factors and consequently of the estimated CV risk. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT02492464. FUNDING IBSA Farmaceutici.
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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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Comparison of Low-Dose Statin Versus Low-Dose Statin + Armolipid Plus in High-Intensity Statin-Intolerant Patients With a Previous Coronary Event and Percutaneous Coronary Intervention (ADHERENCE Trial).
Marazzi, G, Campolongo, G, Pelliccia, F, Quattrino, S, Vitale, C, Cacciotti, L, Massaro, R, Volterrani, M, Rosano, G
The American journal of cardiology. 2017;(6):893-897
Abstract
Low-density lipoprotein cholesterol (LDL-C) reduction is associated with a significant decrease in mortality, and statins represent the most effective drugs to achieve this. However, side effects of statins are very common and may lead to treatment discontinuation. Nutraceuticals are a combination of natural components that have shown efficacy in lowering LDL-C concentration when used alone or in association with other agents in patients who are intolerant to high-dose statins. Our aim was to compare the efficacy and tolerability of low-dose statin (LDS) therapy versus combined therapy of LDS plus a nutraceutical combination containing red yeast rice, policosanol, berberine, folic acid, coenzyme Q10 and astaxanthin (Armolipid Plus) in high-risk patients. We performed a randomized (1:1), prospective, parallel group, single-blind trial in which participants had coronary artery disease (n = 100), had undergone percutaneous coronary intervention in the preceding 12 months, were high-dose statin intolerant, and did not achieve ≥50% reduction in LDL-C with LDS treatment alone. After 3 months, patients in the LDS + Armolipid Plus (n = 50) group presented with a significantly greater reduction of LDL-C and total cholesterol (p <0.0001), and 70% of patients in this group achieved the therapeutic target (LDL-C <70 mg/dl), whereas patients in the LDS group did not. Six patients (3 from each group) dropped out due to myalgia. In conclusion, in patients with coronary artery disease and high-dose statin intolerance, the combination of LDS and nutraceuticals represents a valuable therapeutic option.