Functional foods with added plant sterols for treatment of hypercholesterolaemia and prevention of ischaemic heart disease

Background. A spread with added plant sterols, Pro-activ, is marketed in South Africa as an adjunct to low-fat diets for lowering of total and low-density lipoprotein (LDL) cholesterol concentrations and to decrease risk of ischaemic heart disease (IHD). Objectives. The need for this functional food in South Africa, its efficacy, safety and target market, are evaluated in this review. Results. The high, and probably increasing incidence of hypercholesterolaemia and cardiovascular disease in South Africa motivates the need for appropriate functional foods. There is convincing evidence in the literature that an average daily intake of about 2 g plant sterols in about 20 g of spread significantly lowers total and LDL cholesterol concentrations by approximately 10 - 15%, without influencing high-density lipoprotein (HDL) cholesterol and triglyceride concentrations. There is some concern about the effects on absorption of lipid-soluble vitamins and pro-vitamins, but safety tests lasting for up to 3 years found no serious adverse effects. Conclusions. The target market for this spread should be nonpregnant, non-lactating adults with hypercholesterolaemia and/or increased risk of IHD. If it is considered for use in hypercholesterolaemic children, fat-soluble vitamin status should be monitored. It is recommended that post-marketing surveillance should be established to determine long-term effects and safety

coreNASH: Multi-stakeholder Consensus on Core Outcomes for Decision Making About Nonalcoholic Steatohepatitis Treatment

The increasing prevalence and burden of nonalcoholic steatohepatitis (NASH) has spurred the development of new treatments and a need to consider outcomes used for NASH treatment decision making. Development of a NASH core outcome set (COS) can help prioritize outcomes of highest importance by incorporating the perspectives from a variety of decision makers. coreNASH was an initiative to develop a COS for NASH using a modified Delphi consensus process with a multi-stakeholder voting panel. A candidate outcome list was created based on a literature review and key informant interviews. The candidate outcome list was then condensed and prioritized through three rounds of online voting and through discussion at an in-person meeting. Outcomes were retained or eliminated based on predetermined consensus criteria, which included special weighting of patients’ opinions in the first two voting rounds. The coreNASH Delphi panel included 53 participants (7 patients, 10 clinicians and researchers, 7 health technology assessors, 22 industry representatives, 2 regulators, and 5 payers) who considered outcomes for two NASH-related COS: one for NASH without cirrhosis (F2-F3) and one for NASH with cirrhosis (F4). The initial candidate outcome list for both disease stages included 86 outcomes. The panel agreed on including two core outcomes for NASH without cirrhosis and nine core outcomes for NASH with cirrhosis in the COS. Conclusion: A consensus-based COS has been developed that can be used across the life cycle of NASH treatments. Outcomes included can contribute to decision making for regulatory, market access, and on-market decision making. Including the coreNASH COS in clinical development programs will facilitate improved comparisons and help decision makers assess the value of new products

An increase in dietary carotenoids when consuming plant sterols or stanols is effective in maintaining plasma carotenoid concentrations

BackgroundPlant-sterol-enriched spreads lower LDL cholesterol but may also lower lipid-standardized carotenoids.ObjectiveOur objective was to assess whether advice to consume specific daily amounts of foods high in carotenoids prevents a reduction in plasma carotenoid concentrations in subjects who consume plant sterol or stanol esters.DesignForty-six hypercholesterolemic free-living subjects completed a 3-way, double-blind, randomized crossover comparison. Subjects consumed each of the following 3 spreads (25 g/d) for 3 wk: control-1 (sterol-free), sterol ester-1 (2.3 g plant sterol esters), and stanol ester-1 (2.5 g plant stanol esters). During the 3-wk interventions, subjects were advised to eat > or =5 servings of vegetables and fruit/d, of which > or =1 serving was to be carrots, sweet potatoes, pumpkins, tomatoes, apricots, spinach, or broccoli.ResultsThe dietary advice resulted in a 13% increase in plasma beta-carotene in subjects who consumed control-1 (P = 0.04). The plasma beta-carotene concentrations of subjects who consumed control-1 did not differ significantly from those of subjects who consumed stanol ester-1 or sterol ester-1. This result was achieved by an increase of one daily serving of high-carotenoid vegetables or fruit. LDL cholesterol decreased 7.7% and 9.5% after consumption of sterol ester-1 and stanol ester-1, respectively (P ConclusionDietary advice to consume an additional daily serving of a high-carotenoid vegetable or fruit when consuming spreads containing sterol or stanol esters maintains plasma carotenoid concentrations while lowering LDL-cholesterol concentrations significantly.Manny Noakes, Peter Clifton, Fady Ntanios, William Shrapnel, Ian Record, and Jenny McInerne