The effect of a low-fat spread with added plant sterols on vascular function markers: results of the Investigating Vascular Function Effects of Plant Sterols (INVEST) study

Abstract

Background: Plant sterols (PSs) lower LDL cholesterol, an established risk factor for coronary artery disease (CAD). No direct evidence is available supporting a reduced risk of CAD for foods with added PSs. Endothelial dysfunction is seen as an early indicator of atherosclerotic damage.Objectives: This study was primarily designed to investigate the effect of a low-fat spread with added PSs on brachial artery endothelial function as measured by flow-mediated dilation (FMD). Second, effects on arterial stiffness, blood pressure, serum lipids, and plasma PS concentrations were investigated. We hypothesized that PSs would not worsen FMD but would rather modestly improve FMD.Design: This study had a double-blind, randomized, placebo-controlled, parallel design. After a 4-wk run-in period, 240 hypercholesterolemic but otherwise healthy men and women consumed 20 g/d of low-fat spread without (control) or with added PSs (3 g/d) during 12 wk. Pre- and postintervention, vascular function measurements and blood sampling were performed.Results: In total, 232 participants completed the study period. For the primary endpoint FMD, 199 participants were included in the statistical analysis. PS intake did not affect FMD (+0.01 percentage points; 95% CI: −0.73, 0.75) compared with control. Measures of arterial stiffness (pulse wave velocity and augmentation index) and blood pressure were also not significantly changed compared with control. After PS intervention, LDL cholesterol significantly decreased on average by 0.26 mmol/L (95% CI: −0.40, −0.12) or 6.7% compared with control. Plasma sitosterol and campesterol concentrations significantly increased in the PS group up to on average 11.5 μmol/L and 13.9 μmol/L (expressed as geometric means), respectively.Conclusions: The intake of a low-fat spread with added PSs neither improved nor worsened FMD or other vascular function markers in hypercholesterolemic men and women. As expected, serum LDL cholesterol decreased, whereas plasma PSs increased after PS intake. This study was registered at clinicaltrials.gov as NCT01803178.

Effect of a plant sterol-enriched spread on biomarkers of endothelial dysfunction and low-grade inflammation in hypercholesterolaemic subjects

“…Opened and unopened portion packs were returned and counted to determine compliance. More details on the selection of the study population and the study design have been described elsewhere ( 10 ) .…”

“…This study was part of the INVEST study (INvestigating Vascular function Effects of plant STerols) which was primarily designed to investigate the effect of a low-fat spread with added PS on FMD, and also measured arterial stiffness (pulse wave velocity and augmentation index), blood pressure, serum lipids and plasma PS concentrations ( 10 , 25 ) .…”

Beneficial effects of β-sitosterol on type 1 cholecystokinin receptor dysfunction induced by elevated membrane cholesterol

“…Phytosterols represent a small fraction of dietary sterols, but can be safely administered in substantial quantity, often in an esterified form, as dietary supplements (19, 28–33). Administration of up to 9 g/day has been shown to elicit no side effects or toxicity (33).…”

“…Administration of up to 9 g/day has been shown to elicit no side effects or toxicity (33). Clinical evidence including meta-analysis also shows that β-sitosterol supplementation does not result in any increased risk of developing cardiovascular disease (19, 28). …”

“…Data from clinical studies demonstrating an LDL-lowering effect of β-sitosterol in hypercholesteromic patients have reported serum levels of β-sitosterol of 6–30 μM before treatment, and 8–75 μM after administration (19, 28–32). This is particularly noteworthy, since the serum levels of β-sitosterol achieved are close to the concentrations that showed an improvement in CCK1R signaling in the setting of high membrane cholesterol in vitro in the present study.…”