Safety and Immunogenicity of Heterologous Boosting With a Protein-Subunit-Based COVID-19 Vaccine (ZF2001) in Healthy Adults Previously Received One Dose of Convidecia: A Randomised, Observer-Blinded, Placebo-Controlled Trial

2022 ◽  
Author(s):  
Pengfei Jin ◽  
Xi-Ling Guo ◽  
Wei Chen ◽  
Shihua Ma ◽  
Hong-Xing Pan ◽  
...  
Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 2066
Author(s):  
Oliver Chen ◽  
Traci M. Blonquist ◽  
Eunice Mah ◽  
Kristen Sanoshy ◽  
Dawn Beckman ◽  
...  

Nutritional ketosis is a state of mildly elevated blood ketone concentrations resulting from dietary changes (e.g., fasting or reduced carbohydrate intake) or exogenous ketone consumption. In this study, we determined the tolerability and safety of a novel exogenous ketone diester, bis-hexanoyl-(R)-1,3-butanediol (BH-BD), in a 28-day, randomized, double-blind, placebo-controlled, parallel trial (NCT04707989). Healthy adults (n = 59, mean (SD), age: 42.8 (13.4) y, body mass index: 27.8 (3.9) kg/m2) were randomized to consume a beverage containing 12.5 g (Days 0–7) and 25 g (Days 7–28) of BH-BD or a taste-matched placebo daily with breakfast. Tolerability, stimulation, and sedation were assessed daily by standardized questionnaires, and blood and urine samples were collected at Days 0, 7, 14, and 28 for safety assessment. There were no differences in at-home composite systemic and gastrointestinal tolerability scores between BH-BD and placebo at any time in the study, or in acute tolerability measured 1-h post-consumption in-clinic. Weekly at-home composite tolerability scores did not change when BH-BD servings were doubled. At-home scores for stimulation and sedation did not differ between groups. BH-BD significantly increased blood ketone concentrations 1-h post-consumption. No clinically meaningful changes in safety measures including vital signs and clinical laboratory measurements were detected within or between groups. These results support the overall tolerability and safety of consumption of up to 25 g/day BH-BD.


Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4392
Author(s):  
Karina Cernioglo ◽  
Karen M. Kalanetra ◽  
Anna Meier ◽  
Zachery T. Lewis ◽  
Mark A. Underwood ◽  
...  

Streptococcus salivarius (S. salivarius) K12 supplementation has been found to reduce the risk of recurrent upper respiratory tract infections. Yet, studies have not reported the effect of supplementation on oral S. salivarius K12 levels or the salivary microbiome. This clinical trial was designed to determine how supplementation with S. salivarius K12 influences the oral microbiome. In a randomized, double-blind, placebo-controlled trial, 13 healthy adults received a probiotic powder (PRO) containing Lactobacillus acidophilus, Bifidobacterium lactis, and S. salivarius K12 and 12 healthy adults received a placebo-control powder (CON) (n = 12) for 14 consecutive days. Oral S. salivarius K12 and total bacteria were quantified by qPCR and the overall oral microbiome was measured using 16S rRNA amplicon sequencing. Supplementation significantly increased mean salivary S. salivarius K12 levels by 5 logs compared to baseline for the PRO group (p < 0.0005), which returned to baseline 2 weeks post-supplementation. Compared with the CON group, salivary S. salivarius K12 was 5 logs higher in the PRO group at the end of the supplementation period (p < 0.001). Neither time nor supplementation influenced the overall oral microbiome. Supplementation with a probiotic cocktail containing S. salivarius K12 for two weeks significantly increased levels of salivary S. salivarius K12.


Hypertension ◽  
2012 ◽  
Vol 60 (suppl_1) ◽  
Author(s):  
Janet A Novotny ◽  
David J Baer ◽  
Christina Khoo ◽  
Sarah K Gebauer

Dietary polyphenols have been shown to have a beneficial impact on blood pressure. To investigate the effect of daily consumption of a low calorie cranberry juice beverage (a rich source of polyphenols) on blood pressure of healthy adults (n=56), we conducted a parallel arm, double-blind, randomized, placebo-controlled trial. Volunteers were men (n=26) and women (n=30), aged 51+11 years, with a body weight of 79.3+8.8 kg and BMI of 28.4+4.3 (mean+SD). Treatments were a low calorie cranberry juice beverage or a color/flavor/calorie-matched placebo beverage, both of which were incorporated into a controlled diet for 8 weeks. During the controlled diet, volunteers consumed a base diet, consisting of typical American foods, scaled to meet their individual energy requirement such that body weight did not change during the study. Blood pressure was measured by a standardized protocol at the beginning of the intervention, after 4 weeks of treatment, and after 8 weeks of treatment. Systolic and diastolic blood pressure values for placebo and cranberry juice treatments at 4 weeks and 8 weeks were compared with a mixed model ANOVA. Blood pressure measures at 4 and 8 weeks of treatment for placebo and cranberry juice were also compared to baseline using a repeated measures ANOVA. After 8 weeks, diastolic blood pressure was significantly lower for the cranberry juice group compared to the placebo group (LSmeans + SEM of 72.2+1.1 mm Hg for placebo vs. 68.6+1.1 mm Hg for cranberry juice, respectively, p=0.029). When 8 week blood pressure values were compared to baseline, cranberry juice was associated with a significant decrease in diastolic BP (73.9+1.6 mm Hg at baseline vs. 70.9+1.6 mm Hg at 8 wk, p=0.049) and a trend toward decreased systolic BP (121.9+3.2 mm Hg at baseline vs. 118.6+3.1 mm Hg at 8 wk, p=0.12), while the placebo was associated with no change from baseline (systolic of 111.5+2.4 mm Hg at baseline vs. 112.3+2.2 mm Hg at 8 wk, p=0.89; diastolic of 68.1+1.5 mm Hg at baseline vs. 68.6+1.5 mm Hg at 8 wk, p=0.37). In conclusion, incorporation of a low calorie cranberry juice beverage into the diet of healthy adults appears to result in improvements in blood pressure.


2021 ◽  
Vol 45 (1) ◽  
pp. 191-198
Author(s):  
Sun Hee Hyun ◽  
Ha-Young Ahn ◽  
Hyeong-Jun Kim ◽  
Sung Won Kim ◽  
Seung-Ho So ◽  
...  

2020 ◽  
Vol 20 (10) ◽  
pp. 1193-1203 ◽  
Author(s):  
Nina Wressnigg ◽  
Romana Hochreiter ◽  
Oliver Zoihsl ◽  
Andrea Fritzer ◽  
Nicole Bézay ◽  
...  

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