scholarly journals A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUO®) on LDL Cholesterol Levels and Lipid Pattern in Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study)

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3127
Author(s):  
Arrigo F.G. Cicero ◽  
Sergio D’Addato ◽  
Claudio Borghi
Keyword(s):  
Ldl Cholesterol ◽  
Hdl Cholesterol ◽  
Blood Cholesterol ◽  
Controlled Clinical Trial ◽  
Red Yeast Rice ◽  
Double Blind ◽  
Cholesterol Levels ◽  
Red Yeast ◽  
Significant Difference ◽  
Double Blinded

Phytosterols and red yeast rice are largely studied cholesterol-lowering nutraceuticals, respectively inhibiting the bowel absorption and liver synthesis of cholesterol. Our aim was to test the effect of combined nutraceutical-containing phytosterols and red yeast rice vs. a placebo on the lipid profile. We performed a parallel arms, double-blind, placebo-controlled clinical trial, randomizing 88 moderately hypercholesterolemic subjects to treatment with a combined nutraceutical containing phytosterols (800 mg) and red yeast rice, standardized to contain 5 mg of monacolins from Monascus purpureus, with added niacin (27 mg) and policosanols (10 mg) (LEVELIP DUO®), or placebo. The mean LDL-Cholesterol (LDL-C) change at Week 8 was −32.5 ± 30.2 mg/dL (−19.8%) in the combined nutraceutical group and 2.5 ± 19.4 mg/dL (2.3%) in the placebo group. The estimated between-group difference of −39.2 mg/dL (95% CI: −48.6; −29.8) indicates a statistically significant difference between treatments in favor of the combined nutraceutical (p < 0.0001). Total Cholesterol (TC), non-HDL cholesterol (non-HDL-C), Apolipoprotein B, TC/HDL-C and LDL-C/HDL-C improved in a similar way in the combined nutraceutical group only. No significant changes in other clinical and laboratory parameters were observed. In conclusion, the tested combined nutraceutical was well tolerated, while significantly reducing the plasma levels of LDL-C, TC, non-HDL-C, ApoB, TC/HDL-C and LDL-C/HDL-C ratios in mildly hypercholesterolemic patients. Trial registration (ClinicalTrials.gov): NCT03739242.

scholarly journals A Combination of Lactoplantibacillus plantarum Strains CECT7527, CECT7528 and CECT7529 Plus Monacolin K Reduces Blood Cholesterol: Results from a Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1206
Author(s):  
Rafael Guerrero-Bonmatty ◽  
Guadalupe Gil-Fernández ◽  
Francisco José Rodríguez-Velasco ◽  
Jordi Espadaler-Mazo
Keyword(s):  
Intervention Group ◽  
Study Groups ◽  
Statin Treatment ◽  
Blood Cholesterol ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Red Yeast Rice ◽  
Monacolin K ◽  
Double Blind ◽  
History Of

Background: Dietary supplements have been proposed to help manage blood cholesterol, including red yeast rice (RYR) extracts, plant sterols and stanols, beta-glucans, and some probiotics. This study was conducted to evaluate the efficacy of RYR (containing 10 mg of monacolin K) combined with 109 CFU of three Lactoplantibacillus plantarum strains (CECT7527, CECT7528, and CECT7529). Methods: A 12-week randomized, double-blinded, placebo-controlled clinical trial was conducted. In total, 39 adult patients were enrolled, having total cholesterol (TC) ≥200 mg/dL, and being statin-naïve or having recently stopped statin treatment because of intolerance. Active product or placebo were taken once daily, and subjects were evaluated at baseline, 6, and 12 weeks. Results: Study groups were comparable at baseline, except for history of recent hypercholesterolemia treatment (81% in active vs. 22% in placebo). Changes in LDL cholesterol and TC became significant compared to placebo (mean difference between groups and standard error of the mean = 23.6 ± 1.5 mg/dL, p = 0.023 and 31.4 ± 1.9 mg/dL, p = 0.011, respectively) upon adjusting for the baseline imbalance in hypercholesterolemia treatment. No adverse effects were noted during the study. Conclusion: This combination of 10 mg of monacolin K and L. plantarum strains was well tolerated and achieved a statistically significant greater reduction in LDL-C and TC in the intervention group compared to the placebo, once adjusting for recent history of hypercholesterolemia treatment.

Paradoxical Hypercholesterolemia in an Otherwise Healthy Adult Man

2019 ◽  
Author(s):  
Peter A Mcpherson
Keyword(s):  
Cholesterol Level ◽  
Total Cholesterol Level ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Hdl Cholesterol ◽  
Red Yeast Rice ◽  
Transfer Protein ◽  
Cholesterol Levels ◽  
Red Yeast ◽  
High High Density Lipoprotein

AbstractHypercholesterolemia is characterized by serum cholesterol levels greater than 5 mmol per L. However, the distribution of cholesterol among lipoprotein classes has a significant bearing on diagnosis: high–low-density lipoprotein (LDL) cholesterol suggests familial hypercholesterolemia, whereas high–high-density lipoprotein (HDL) cholesterol is associated with hyperalphalipoproteinemia. On routine screening, a 23-year-old man presented with a total cholesterol level of 7.6 mmol per L but was subsequently found to have an HDL cholesterol level of 5.6 mmol per L. The clinical picture was confounded by his use of red yeast rice extract, a popular health supplement with hypolipidemic effects. In this case individual, the use of red yeast rice extract caused a hyperlipidemic state, ostensibly through downregulation of cholesteryl ester transfer protein. This case emphasizes the extended role of laboratory medicine in complex cases of hyperlipidemia.

scholarly journals Validation Study of Kim's Sham Needle by Measuring Facial Temperature: An N-of-1 Randomized Double-Blind Placebo-Controlled Clinical Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Sanghun Lee ◽  
Nara Lim ◽  
Sun Mi Choi ◽  
Sungchul Kim
Keyword(s):  
Thermal Imaging ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Infrared Thermal Imaging ◽  
Double Blind Placebo ◽  
Control Intervention ◽  
Significant Difference ◽  
Double Blinded ◽  
Stimulation Of

Introduction. In 2008, Kim's sham needle was developed to improve the quality of double-blinded studies. The aim of this study is to validate Kim's sham needle by measuring facial temperature.Methods. We designed “N-of-1” trials involving 7 smokers. One session was composed of 2 stimulations separated by a 2 h washout period. Six sessions were applied daily for all subjects. Infrared thermal imaging was used to examine the effects of acupuncture (HT8, KI2) on facial temperature following smoking-induced decrease.Results. All subjects demonstrated decreased temperatures after sham needle treatment, but 5 of the 7 subjects showed increased temperatures after real needle treatment. 6 of the 7 subjects showed a significant difference(P<0.05)between treatments with real and sham needles. Thus, the physiological stimulation of Kim's sham needle is different from that of a real needle, suggesting that Kim's sham needle is a potential inactive control intervention.

scholarly journals Spreads enriched with plant sterols, either esterified 4,4-dimethylsterols or free 4-desmethylsterols, and plasma total- and LDL-cholesterol concentrations

1999 ◽  
Vol 82 (4) ◽  
pp. 273-282 ◽  
Author(s):  
Aafje Sierksma ◽  
Jan A. Weststrate ◽  
Gert W. Meijer
Keyword(s):  
Vegetable Oil ◽  
Ldl Cholesterol ◽  
Clinical Chemistry ◽  
Daily Intake ◽  
Plasma Lipid ◽  
Hdl Cholesterol ◽  
Blood Levels ◽  
Double Blind ◽  
Cholesterol Levels ◽  
Induced Changes

In a 9-week study seventy-six healthy adult volunteers with an average age of 44 (sd11) years, with baseline plasma total cholesterol levels below 8 mmol/l, received in a balanced, double-blind, crossover design, a total of three different table spreads for personal use. Two spreads were fortified either with free (non-esterified) vegetable-oil sterols, mainly from soyabean oil (31 g sterol equivalents/kg; 0·8 g/d) or sheanut-oil sterols (133 g sterol equivalents/kg; 3·3 g/d). One spread was not fortified (control). Average intake of spread was 25 g/d for 3 weeks. None of the spreads induced changes in blood clinical chemistry or haematology. Plasma total- and LDL-cholesterol concentrations were statistically significantly reduced by 3·8% and 6% (both 0·19 mmol/l) respectively, for the spread enriched with free soyabean-oil sterols compared with the control spread. The spread enriched with sheanut-oil sterols did not lower plasma total- and LDL-cholesterol levels. None of the plant-sterol-enriched spreads affected plasma HDL-cholesterol concentrations. Plasma-lipid-standardized concentrations of α- plus β-carotene were not statistically significantly affected by the soyabean-oil sterol spread in contrast to lipid-standardized plasma lycopene levels which showed a statistically significant decrease (9·5%). These findings indicate that a daily intake of free soyabean-oil sterols as low as 0·8 g added to a spread is effective in lowering blood total- and LDL-cholesterol levels with limited effects on blood carotenoid levels. The lowering in total- and LDL-cholesterol blood levels due to consumption of the vegetable-oil-sterol-enriched spread may be helpful in reducing the risk of CHD for the population.

scholarly journals Effect of soya protein on serum lipid profile and lipoprotein concentrations in patients undergoing hypercholesterolaemic haemodialysis

2006 ◽  
Vol 95 (2) ◽  
pp. 366-371 ◽  
Author(s):  
Shu-Tzu Chen ◽  
Jiun-Rong Chen ◽  
Chwei-Shiun Yang ◽  
Sheng-Jeng Peng ◽  
Shyang-Hwa Ferng
Keyword(s):  
Total Cholesterol ◽  
Serum Lipid ◽  
Milk Protein ◽  
Ldl Cholesterol ◽  
Lipoprotein Metabolism ◽  
Hdl Cholesterol ◽  
Soya Protein ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Apo B

Clinical trials have shown that soya protein reduces the concentrations of some atherogenic lipids in subjects with normal renal function. The present study examined the effects of soya protein on serum lipid concentrations and lipoprotein metabolism in patients on hypercholesterolaemic haemodialysis. Twenty-six hypercholesterolaemic (total cholesterol ≥6·21mmol/l) patients on haemodialysis were studied in a randomized, double-blind, placebo-controlled clinical trial. After a 4-week run-in phase, the subjects were randomly assigned to two groups. Isolated soya protein or milk protein 30g was consumed daily as a beverage at breakfast or post-dialysis for 12 weeks. Soya protein substitution resulted in significant reductions in total cholesterol (17·2 (sd8·9)%), LDL-cholesterol (15·3 (sd12·5)), apo B (14·6 (sd12·1)%) and insulin (23·8 (sd18·7)%) concentrations. There were no significant changes in HDL-cholesterol or apo A-I. These results indicate that replacing part of the daily protein intake with soya protein has a beneficial effect on atherogenic lipids and favourably affects lipoprotein metabolism in hypercholesterolaemic patients undergoing haemodialysis.

scholarly journals Consumption of tall oil-derived phytosterols in a chocolate matrix significantly decreases plasma total and low-density lipoprotein-cholesterol levels

2002 ◽  
Vol 88 (5) ◽  
pp. 479-488 ◽  
Author(s):  
Jacqueline de Graaf ◽  
Pernette R. W. de Sauvage Nolting ◽  
Marjel van Dam ◽  
Elizabeth M. Belsey ◽  
John J. P. Kastelein ◽  
...  
Keyword(s):  
Ldl Cholesterol ◽  
Controlled Trial ◽  
Density Lipoprotein ◽  
Hdl Cholesterol ◽  
Cholesterol Absorption ◽  
Tall Oil ◽  
Double Blind ◽  
Intestinal Cholesterol Absorption ◽  
Primary Hypercholesterolaemia ◽  
Cholesterol Levels

In a randomized, double-blind, placebo-controlled trial we evaluated the effect of dietary chocolates enriched with a wood-based phytosterol–phytostanol mixture, containing 18% (w/w) sitostanol, compared with placebo dietary chocolates in seventy subjects with primary hypercholesterolaemia (total cholesterol levels below 8 mmol/l). For 4 weeks, participants consumed three servings of the phytosterol-enriched chocolate/d that provided 1·8 g unesterified phytosterols/d or a placebo chocolate in conjunction with a low-fat, low-cholesterol diet. Plasma total and LDL-cholesterol levels were statistically significantly reduced by 6·4% (−0·44 mmol/l) and 10·3% (−0·49 mmol/l), respectively, after 4 weeks of phytosterol-enriched-chocolate treatment. Plasma HDL-cholesterol and triacylglycerol levels were not affected. Consumption of phytosterol-enriched chocolates significantly increased plasma lathosterol concentration (+20·7%), reflecting an increased endogenous cholesterol synthesis in response to phytosterol-induced decreased intestinal cholesterol absorption. Furthermore, the chocolates enriched with phytosterols significantly increased both plasma sitosterol (+95·8%) and campesterol (+64·1%) levels, compared with the placebo chocolate group. However, the absolute values of plasma sitosterol and campesterol remained within the normal range, that is, below 10 mg/l. The chocolates with phytosterols were palatable and induced no clinical or biochemical side effects. These findings indicate that dietary chocolate enriched with tall oil-derived phytosterols (1·8 g/d) is effective in lowering blood total and LDL-cholesterol levels in subjects with mild hypercholesterolaemia and thus may be helpful in reducing the risk of CHD in these individuals.

scholarly journals Cholesterol lowering in pigs through enhanced bacterial bile salt hydrolase activity

1998 ◽  
Vol 79 (2) ◽  
pp. 185-194 ◽  
Author(s):  
I. De Smet ◽  
P. De Boever ◽  
W. Verstraete
Keyword(s):  
Bile Salt ◽  
Ldl Cholesterol ◽  
Lactobacillus Reuteri ◽  
Plasma Cholesterol ◽  
Hdl Cholesterol ◽  
Blood Cholesterol ◽  
Cholesterol Concentration ◽  
Control Group ◽  
Bile Salt Hydrolase ◽  
Cholesterol Levels

The effect of feeding liveLactobacillus reutericells containing active bile salt hydrolase (BSH) on plasma cholesterol levels was studied in pigs. During an experiment lasting 13 weeks, twenty pigs were fed on a high-fat, high-cholesterol, low-fibre diet for the first 10 weeks, and a regular pig diet for the last 3 weeks. One group of animals received, twice daily, 11·25 (SD 0·16) log10colony forming units of the potential probiotic bacteria for 4 weeks (from week 3 until week 7). From week 8 onwards, the treated group was again fed on the same diet as the control group without additions. The total faecalLactobacilluscounts were only significantly higher in the treated pigs during the first 2 weeks ofL. reuterifeeding. Based on limited data, it was suggested that the administeredLactobacillusspecies had caused a temporary shift within the indigenousLactobacilluspopulation rather than permanently colonizing the intestinal tract. The probiotic feeding brought about significant lowering (P≤ 0·05) of total and LDL-cholesterol concentrations in the treated pigs compared with the control pigs, while no change in HDL-cholesterol concentration was observed. The data for faecal output of neutral sterols and bile salts were highly variable between the animals of each group, yet they indicated an increased output in the treated pigs. Although the blood cholesterol levels went up in both groups during the 3 weeks following theLactobacillusadministration period, significantly lower serum total and LDL-cholesterol levels were observed in the treated pigs. During the final 3 weeks of normalization to the regular diet, cholesterol concentrations significantly decreased in both animal groups and the differences in total and LDL-cholesterol concentrations between the groups largely disappeared.

Lipid Responses in Mildly Hypertriglyceridemic Men and Women to Consumption of Docosahexaenoic Acid-Enriched Eggs

2003 ◽  
Vol 73 (5) ◽  
pp. 357-368 ◽  
Author(s):  
Maki ◽  
Van Elswyk ◽  
McCarthy ◽  
Seeley ◽  
Veith ◽  
...  
Keyword(s):  
Docosahexaenoic Acid ◽  
Density Lipoprotein ◽  
Serum Triglyceride ◽  
Hdl Cholesterol ◽  
Controlled Clinical Trial ◽  
Nuclear Magnetic Resonance Analysis ◽  
Double Blind ◽  
Men And Women ◽  
Cholesterol Levels ◽  
Ldl Particles

This randomized, double-blind, controlled clinical trial assessed lipid responses in mildly hypertriglyceridemic men and women to consumption of docosahexaenoic acid (DHA)-enriched eggs or ordinary chicken eggs. The study included 153 subjects aged 21–80 years, with serum triglyceride concentrations between 140 and 450 mg/dL, inclusive, and serum total cholesterol concentrations < 300 mg/dL. Subjects were randomly assigned to receive either DHA-enriched (147 mg DHA/egg) or ordinary eggs (20 mg DHA/egg), added to their usual diets for six weeks (10 eggs/week). Both treatments significantly lowered triglycerides and increased high-density lipoprotein (HDL) cholesterol levels from baseline; however, these changes were not significantly different between treatments. Low-density lipoprotein (LDL) cholesterol concentrations increased significantly in subjects who consumed DHA-enriched eggs (p = 0.047 vs. control). This increase was significantly higher than that observed with ordinary eggs. However, there was no significant increase in cholesterol carried by small, dense LDL particles, as determined by nuclear magnetic resonance analysis. Results of exploratory analyses suggest favorable effects of the DHA-enriched eggs over ordinary eggs on triglyceride and HDL cholesterol levels in subjects with body mass index ≥ 30 kg/m2; the DHA treatment produced a larger reduction in serum triglyceride concentration vs. ordinary eggs (–12.3 vs. 2.1%; p = 0.027), and there was a greater increase for HDLcholesterol in the DHA-enriched vs. ordinary egg group (5.0 vs. 1.1%; p = 0.040).

scholarly journals Update on the Benefits and Mechanisms of Action of the Bioactive Vegetal Alkaloid Berberine on Lipid Metabolism and Homeostasis

Cholesterol ◽  
2018 ◽  
Vol 2018 ◽  
pp. 1-17 ◽  
Author(s):  
Yanwen Wang ◽  
Jeffrey A. Zidichouski
Keyword(s):  
Ldl Cholesterol ◽  
Hdl Cholesterol ◽  
Bioactive Compound ◽  
Mechanisms Of Action ◽  
Blood Cholesterol ◽  
Alternative Intervention ◽  
Cholesterol Levels ◽  
New Concepts ◽  
Cerebrovascular Events ◽  
Circulating Levels

Elevation of circulating levels of blood cholesterol, especially LDL cholesterol, and/or the decrease of HDL cholesterol levels have long been recognized as primary risk factors for developing atherosclerosis that leads to cardiovascular and cerebrovascular disease. Hypertriglyceridemia is an independent risk factor that is known to contribute to the development of atherosclerosis. Thus, various interventional efforts aimed at reducing hypercholesterolemia and hypertriglyceridemia have been practiced clinically for decades to reduce morbidity and mortality risk associated with deleterious cardiovascular and cerebrovascular events. As such, many drugs have been developed and clinically used to treat hypocholesteremia and/or hypertriglyceridemia; however, dietary approaches including supplements along with changes in nutrition and lifestyle have become increasingly attractive and acceptable methods used to control borderline or moderately increased levels of blood cholesterol and triacylglycerols. In this regard, the use of a plant/herbal bioactive compound, berberine (BBR), has recently been studied extensively in terms of its efficacy as well as its mechanisms of action and safety as an alternative intervention that beneficially modulates blood lipids. The aim of this review is to provide a comprehensive update on BBR research, new concepts and directions in terms of product development and current challenges, and future prospects of using BBR to manage diseases and complications associated with dyslipidemia.

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