Benecol (sitostanol ester) / J&J, Raisio - LARVOL DELTA

The effects of three different daily plant stanol ester intakes on influenza vaccination responses: a double-blind, randomized, placebo-controlled intervention study in older adults. (PubMed, Food Funct) - "No between-group differences in haematological and immunological parameters were observed. Daily consumption of 2, 3 or 4 g of plant stanols provided as fatty-acid esters, did not improve vaccination responses following annual influenza vaccination in men and women aged 60 years or older."

Journal • Hematological Disorders • Infectious Disease • Influenza • Respiratory Diseases

Associations between dietary patterns and sarcopenia: insights from cross-sectional and Mendelian randomization analyses. (PubMed, J Int Soc Sports Nutr) - "Preference for FloraPro-Active/Benecol in spreads also relates to a reduced risk...MR confirmed the causal effects of coffee intake on low hand grip strength and ALM. Our study provides insights for dietary strategies in sarcopenia patients, though further research is needed to validate and explore these mechanisms."

Journal • Addiction (Opioid and Alcohol) • Sarcopenia

Heart-healthy diets including phytostanol ester consumption to reduce the risk of atherosclerotic cardiovascular diseases. A clinical review. (PubMed, Lipids Health Dis) - "This information can be used, in particular, to prevent the development of subclinical atherosclerosis in healthy middle-aged populations and the progression of atherosclerosis to ASCVD. The outcome of simple and feasible dietary changes, and, when needed, combined with statins, can be significant: reduced mortality, an increased number of healthy life-years, and reduced healthcare costs."

Journal • Review • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Dyslipidemia

Plant stanol consumption increases anti-COVID-19 antibody responses, independent of changes in serum cholesterol concentrations: a randomized controlled trial. (PubMed, Am J Clin Nutr) - P=N/A | "Consuming plant stanols (4g/day) affects immune responses to COVID-19 vaccinations, translating into increased serum anti-COVID-19 IgM concentrations in subjects with overweight/obesity. Only in IgG seroconverted subjects, serum anti-COVID-19 IgG concentrations also increased. These effects were independent of reductions in LDL cholesterol. These results suggest that this high-risk group for COVID-19 complications could benefit from plant stanol consumption. Clinical Trial Registry website and number: clinicaltrials.gov, NCT04844346."

Journal • Asthma • Dyslipidemia • Genetic Disorders • Hepatology • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Obesity • Pulmonary Disease • Respiratory Diseases

Plant Stanol Esters and Influenza Vaccination (clinicaltrials.gov) - P=N/A | N=137 | Completed | Sponsor: Maastricht University Medical Center

New trial • Infectious Disease • Influenza • Respiratory Diseases • CRP

Plant Stanol Esters and COVID-19 Vaccination Response (clinicaltrials.gov) - P=N/A | N=48 | Terminated | Sponsor: Maastricht University Medical Center | N=100 ➔ 48 | Trial completion date: Aug 2021 ➔ Jan 2022 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2021 ➔ Jan 2022; Recruitment was dependent on finding participants that had to receive an initial COVID-19 vaccination and we were unable to find new participants anymore.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease • Obesity • CRP

Lipid Lowering Effect of Plant Stanol Ester in a Drinkable Non-dairy Product (clinicaltrials.gov) - P=N/A; N=60; Recruiting; Sponsor: Raisio Group

New trial • Dyslipidemia • Metabolic Disorders

Lipid Lowering Effect of Plant Stanol Ester in a Spoonable Non-dairy Product (clinicaltrials.gov) - P=N/A; N=60; Recruiting; Sponsor: Raisio Group

Clinical • New trial • Dyslipidemia • Metabolic Disorders

Effects of Plant Sterols and Stanols on Liver Inflammation (clinicaltrials.gov) - P=N/A; N=8; Recruiting; Sponsor: Maastricht University Medical Center

Clinical • New trial • Hepatology • Immunology • Inflammation • Non-alcoholic Steatohepatitis

Obesity Does Not Interfere with the Cholesterol-Lowering Effect of Plant Stanol Ester Consumption (as Part of a Heart-Healthy Diet). (PubMed, J Cardiovasc Dev Dis) - "However, relative and dietary cholesterol absorption were more effectively reduced in normal-weight subjects. In conclusion, overweight/obesity did not interfere with the serum cholesterol response to plant stanol ester consumption despite substantial differences in cholesterol metabolism between the groups."

Clinical • Journal • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Genetic Disorders • Obesity

Plant stanol esters and COVID-19 vaccination response Plantenstanolen en de COVID-19 vaccinatierespons (clinicaltrialsregister.eu) - P4; N=100; Ongoing; Sponsor: Maastricht University

New P4 trial • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease • Obesity

Plant Stanol Esters and COVID-19 Vaccination Response (clinicaltrials.gov) - P=N/A; N=100; Recruiting; Sponsor: Maastricht University Medical Center; Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease • Obesity

Plant Stanol Esters and COVID-19 Vaccination Response (clinicaltrials.gov) - P=N/A; N=100; Not yet recruiting; Sponsor: Maastricht University Medical Center

New trial • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease • Obesity

Formulation and Characterization of Phytostanol Ester Solid Lipid Nanoparticles for the Management of Hypercholesterolemia: An ex vivo Study. (PubMed, Int J Nanomedicine) - "The formulation has the potential to provide an innovative drug delivery system for phytostanols which reduce cholesterol and have a potentially ideal safety profile. This can contribute to better management of one of the main risk factors of cardiovascular diseases."

Journal • Preclinical • Cardiovascular • Dyslipidemia • Metabolic Disorders

Plant Stanols and Liver Inflammation in Overweight and Obese Children (clinicaltrials.gov) - P=N/A; N=52; Not yet recruiting; Sponsor: Maastricht University Medical Center

Clinical • New trial • Genetic Disorders • Hepatitis C Virus • Hepatology • Immunology • Inflammation • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity • Pediatrics • APOA1

Dietary plant stanol ester supplementation reduces peripheral symptoms in a mouse model of Niemann-Pick type C1 disease. (PubMed, J Lipid Res) - "Overall, these effects were stronger following dietary supplementation with 6% stanols, suggesting a dose-dependent effect. The findings of our study highlight the potential use of plant stanols as an affordable complementary means to ameliorate disorders in hepatic and blood lipid metabolism and reduce inflammation in NPC1 disease."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Hepatology • Immunology • Inflammation • Lysosomal Storage Diseases • Metabolic Disorders • Non-alcoholic Steatohepatitis • Rare Diseases

Plant Stanol Esters Reduce LDL (Low-Density Lipoprotein) Aggregation by Altering LDL Surface Lipids: The BLOOD FLOW Randomized Intervention Study. (PubMed, Arterioscler Thromb Vasc Biol) - P=N/A | "Consumption of plant stanol esters decreases the aggregation susceptibility of LDL particles by modifying LDL lipidome. The resulting improvement of LDL quality may be beneficial for cardiovascular health."

Clinical • Journal • Atherosclerosis • Cardiovascular • Dyslipidemia

Lowering Low-Density Lipoprotein Cholesterol Concentration with Plant Stanol Esters to Reduce the Risk of Atherosclerotic Cardiovascular Disease Events at a Population Level: A Critical Discussion. (PubMed, Nutrients) - "We also present new estimates on the effect of plant stanol ester consumption on LDL-C levels and the risk of ASCVD events. Plant stanol esters as part of a heart-healthy diet plausibly offer a means to reduce the risk of ASCVD events at a population level. This approach is not only appropriate for subjects with a high risk of ASCVD, but also for subjects at an apparently lower risk to prevent subclinical atherosclerosis."

Clinical • Journal • Atherosclerosis • Cardiovascular • Dyslipidemia

Dietary plant stanol ester supplementation reduces peripheral symptoms in a mouse model of Niemann-Pick type C1 disease. (PubMed, J Lipid Res) - "Overall, these effects were stronger following dietary supplementation with 6% stanols, suggesting a dose-dependent effect. The findings of our study highlight the potential use of plant stanols as an affordable complementary means to ameliorate disorders in hepatic and blood lipid metabolism and reduce inflammation in NPC1 disease."

Journal • Addiction (Opioid and Alcohol) • Atherosclerosis • Cardiovascular • CNS Disorders • Dyslipidemia • Gastroenterology • Hepatology • Immunology • Lysosomal Storage Diseases • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Psychiatry • Rare Diseases

DIETARY SATURATED FATS INCREASE AND PLANT STANOL ESTERS DECREASES LDL AGGREGATION (EAS 2019) - "Excess consumption of saturated fats increases while consumption of plant stanol ester enriched spread decreases LDL aggregation susceptibility. Thus, these dietary changes appear to influence, in addition to LDL levels, also LDL quality, and potentially the future risk of cardiovascular disease."

Decreasing the Cholesterol Burden in Heterozygous Familial Hypercholesterolemia Children by Dietary Plant Stanol Esters. (PubMed, Nutrients) - "...The cumulative exposure of coronary arteries to the lifelong LDL-C elevation can be estimated by calculating the LDL-C burden (LDL-C level × years), and it can also be used to demonstrate the usefulness of dietary stanol ester treatment. Thus, when compared with untreated he-FH patients, the LDL-C burden of using statin from the age of 10 is 15% less, and if he-FH patients starts to use dietary stanol from six years onwards and a combination of statin and dietary stanol from 10 years onwards, the LDL-C burden is 21% less compared to non-treated he-FH patients. We consider dietary stanol treatment of he-FH children as a part of the LDL-C-lowering treatment package as safe and cost-effective, and particularly applicable for the family-centered care of the entire he-FH families."

Clinical • Journal • Review