scholarly journals A Randomized, Placebo-Controlled, Double-Blind Crossover Study to Assess a Unique Phytosterol Ester Formulation in Lowering LDL Cholesterol Utilizing a Novel Virtual Tracking Tool

Nutrients ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 2108 ◽  
Author(s):  
Ashley Reaver ◽  
Susan Hewlings ◽  
Kenneth Westerman ◽  
Gil Blander ◽  
Thorsten Schmeller ◽  
...  

Elevated blood concentration of low-density lipoprotein cholesterol (LDLc) is a primary risk factor for developing cardiovascular disease. Lifestyle interventions including an increase in dietary phytosterols as well as medications have proven effective in lowering LDLc. The primary objective of this randomized, placebo controlled, double blind, crossover study was to determine the impact of a new phytosterol emulsion for dietary supplements (1.5 g/day phytosterol equivalents) on LDLc concentrations. Thirty-two healthy adults were randomly assigned to receive placebo or treatment followed by a washout period, followed by placebo or treatment, each phase lasting one month. Secondary endpoints related to cardiovascular health were also assessed. Study management, including screening, recruitment, monitoring, compliance, and data collection, were done remotely (a siteless clinical trial) utilizing a novel virtual tool. Phytosterol supplementation significantly lowered LDLc concentrations by 10.2% (16.17 mg/dL or 0.419 mmol/L, p = 0.008 by paired t-test, p = 0.014 by Wilcoxon signed rank testing). No secondary biomarkers were found to change significantly. Supplementation with phytosterols in a new dietary supplement formulation efficiently and safely decreases LDLc within one month in a free-living setting.

2017 ◽  
Vol 18 (7) ◽  
pp. 567-571 ◽  
Author(s):  
RS Dhanya ◽  
VJ Adarsh ◽  
Md Jalaluddin ◽  
UB Rajasekaran ◽  
CB Sudeep

ABSTRACT Aim The present study aimed at evaluating the impact of neemcontaining mouthwash on plaque and gingivitis. Materials and methods This randomized, double-blinded, crossover clinical trial included 40 participants aged 18 to 35 years with washout period of 1 week between the crossover phases. A total of 20 participants, each randomly allocated into groups I and II, wherein in the first phase, group I was provided with 0.2% chlorhexidine gluconate and group II with 2% neem mouthwash. After the scores were recorded, 1-week time period was given to the participants to carry over the effects of the mouthwashes and then the second phase of the test was performed. The participants were instructed to use the other mouthwash through the second test phase. Results There was a slight reduction of plaque level in the first phase as well as in the second phase. When comparison was made between the groups, no statistically significant difference was seen. Both the groups showed reduction in the gingival index (GI) scores in the first phase, and there was a statistically significant difference in both groups at baseline and after intervention (0.005 and 0.01 respectively). In the second phase, GI scores were reduced in both groups, but there was a statistically significant difference between the groups only at baseline scores (0.01). Conclusion In the present study, it has been concluded that neem mouthwash can be used as an alternative to chlorhexidine mouthwash based on the reduced scores in both the groups. Clinical significance Using neem mouthwash in maintaining oral hygiene might have a better impact in prevention as well as pervasiveness of oral diseases as it is cost-effective and easily available. How to cite this article Jalaluddin M, Rajasekaran UB, Paul S, Dhanya RS, Sudeep CB, Adarsh VJ. Comparative Evaluation of Neem Mouthwash on Plaque and Gingivitis: A Double-blind Crossover Study. J Contemp Dent Pract 2017;18(7):567-571.


Nutrients ◽  
2019 ◽  
Vol 11 (2) ◽  
pp. 417 ◽  
Author(s):  
Janina Rynarzewski ◽  
Lisa Dicks ◽  
Benno Zimmermann ◽  
Birgit Stoffel-Wagner ◽  
Norbert Ludwig ◽  
...  

Randomized controlled trials indicate that flavanol-rich cocoa intake may improve postprandial glucose and lipid metabolism in patients with type 2 diabetes (T2D), based on studies with meals that impose a strong metabolic load. Hence, the aim of the present study was to investigate whether flavanol-rich cocoa powder ingested as part of a diabetic-suitable meal may beneficially affect glucose, lipid metabolism, and blood pressure (BP) in patients with T2D. Twelve adults with T2D, overweight/obesity, and hypertension ingested capsules with 2.5 g of flavanol-rich cocoa or microcrystalline cellulose with a diabetic-suitable breakfast in a randomized, placebo-controlled, double-blind crossover study. BP was measured and blood samples were taken before, 2 and 4 h after breakfast and capsule intake. Cocoa treatment did not affect glucose, insulin, homeostasis model assessment for insulin resistance (HOMA-IR), triglycerides, total cholesterol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, and BP. For glucose, insulin and HOMA-IR, only effects by time were observed after both treatments. Thus, 2.5 g of flavanol-rich cocoa powder ingested as part of a diabetic-suitable meal does not seem to affect postprandial glucose and lipid metabolism and BP in stably-treated diabetics. Nevertheless, future studies with close-meshed investigations are desirable, providing realistic amounts of cocoa together with realistic meals rich in carbohydrates to subjects with T2D or metabolic syndrome, which do not afford pharmacological treatment.


1979 ◽  
Vol 42 (02) ◽  
pp. 621-625 ◽  
Author(s):  
G G Nenci ◽  
G Agnelli ◽  
M Berrettini ◽  
P Parise ◽  
E Ballatori

SummaryIn a randomized double-blind crossover study in 16 patients with enhanced in vitro spontaneous platelet aggregation, sulfinpyrazone proved to be effective in normalizing platelet aggregability within 4 days after initiation of therapy.


Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 696
Author(s):  
Neus Bosch-Sierra ◽  
Roger Marqués-Cardete ◽  
Aránzazu Gurrea-Martínez ◽  
Carmen Grau-Del Valle ◽  
Clara Talens ◽  
...  

The authors have requested that the following changes be made to their paper [...]


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