title: 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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
authors: From Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands (RTR, DF, WPK, UG, AG, CV, HB, and EAT), and Charité Research Organisation, Berlin, Germany (CK and FW).
authors: Rouyanne T
authors: RT
authors: Ras
authors: From Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands (RTR, DF, WPK, UG, AG, CV, HB, and EAT), and Charité Research Organisation, Berlin, Germany (CK and FW).
authors: Dagmar
authors: D
authors: Fuchs
authors: From Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands (RTR, DF, WPK, UG, AG, CV, HB, and EAT), and Charité Research Organisation, Berlin, Germany (CK and FW).
authors: Wieneke P
authors: WP
authors: Koppenol
authors: From Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands (RTR, DF, WPK, UG, AG, CV, HB, and EAT), and Charité Research Organisation, Berlin, Germany (CK and FW).
authors: Ursula
authors: U
authors: Garczarek
authors: From Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands (RTR, DF, WPK, UG, AG, CV, HB, and EAT), and Charité Research Organisation, Berlin, Germany (CK and FW).
authors: Arno
authors: A
authors: Greyling
authors: From Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands (RTR, DF, WPK, UG, AG, CV, HB, and EAT), and Charité Research Organisation, Berlin, Germany (CK and FW).
authors: Christian
authors: C
authors: Keicher
authors: From Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands (RTR, DF, WPK, UG, AG, CV, HB, and EAT), and Charité Research Organisation, Berlin, Germany (CK and FW).
authors: Carole
authors: C
authors: Verhoeven
authors: From Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands (RTR, DF, WPK, UG, AG, CV, HB, and EAT), and Charité Research Organisation, Berlin, Germany (CK and FW).
authors: Hakim
authors: H
authors: Bouzamondo
authors: From Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands (RTR, DF, WPK, UG, AG, CV, HB, and EAT), and Charité Research Organisation, Berlin, Germany (CK and FW).
authors: Frank
authors: F
authors: Wagner
authors: From Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands (RTR, DF, WPK, UG, AG, CV, HB, and EAT), and Charité Research Organisation, Berlin, Germany (CK and FW).
authors: Elke A
authors: EA
authors: Trautwein
mesh_terms: D015415:Biomarkers / Q000097:blood*; D001916:Brachial Artery / Q000187:drug effects* / Q000378:metabolism; D002784:Cholesterol / Q000031:analogs & derivatives / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004040:Dietary Carbohydrates / Q000008:administration & dosage; D004041:Dietary Fats / Q000008:administration & dosage; D004044:Dietary Proteins / Q000008:administration & dosage; D004311:Double-Blind Method; D023381:Endpoint Determination; D002149:Energy Intake; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood; D008019:Life Style; D008297:Male; D008875:Middle Aged; D010840:Phytosterols / Q000008:administration & dosage / Q000097:blood*; D063177:Pulse Wave Analysis; D012855:Sitosterols / Q000097:blood; D014280:Triglycerides / Q000097:blood
chemical_list: D015415:Biomarkers; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004040:Dietary Carbohydrates; D004041:Dietary Fats; D004044:Dietary Proteins; D010840:Phytosterols; D012855:Sitosterols; D014280:Triglycerides; C021273:campesterol; C025473:gamma-sitosterol; D002784:Cholesterol
keywords: cholesterol; flow-mediated dilation; plant sterols; randomized controlled trial; vascular function