Evidence map›Paper›PMID 25809853›Full record

Trial reportThe American journal of clinical nutrition2015

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.

Rouyanne T Ras, Dagmar Fuchs, Wieneke P Koppenol, Ursula Garczarek, Arno Greyling, Christian Keicher, Carole Verhoeven, Hakim Bouzamondo, Frank Wagner, Elke A Trautwein

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of clinical nutrition, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01803178 (The Effect of Plant Sterols on Vascular Function), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01803178 nacompletednot on this map

The Effect of Plant Sterols on Vascular Function

TypeinterventionalSponsorUnilever R&DRan2013 to 2013Enrolled240ConditionsVascular Diseases, HypercholesterolemiaArmsPlant Sterols, Placebo Product
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Molecular Docking Study of Phytosterols inJournal of experimental pharmacology · 2023
    Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Potential role of phytochemicals in metabolic syndrome prevention and therapy.Diabetes, metabolic syndrome and obesity : targets and therapy · 2019
    Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Rouyanne T RasFrom 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).
Dagmar FuchsFrom 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).
Wieneke P KoppenolFrom 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).
Ursula GarczarekFrom 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).
Arno GreylingFrom 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).
Christian KeicherFrom 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).
Carole VerhoevenFrom 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).
Hakim BouzamondoFrom 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).
Frank WagnerFrom 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).
Elke A TrautweinFrom 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).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlant 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.

objectivesThis 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.

designThis 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.

resultsIn 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.

conclusionsThe 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.

Indexed as

BiomarkersBrachial ArteryCholesterolCholesterol, HDLCholesterol, LDLDietary CarbohydratesDietary FatsDietary ProteinsDouble-Blind MethodEndpoint DeterminationEnergy IntakeFemaleHumansHypercholesterolemiaLife StyleMaleBiomarkerscampesterolCholesterolCholesterol, HDLCholesterol, LDLDietary CarbohydratesDietary FatsDietary Proteinsgamma-sitosterolPhytosterolsSitosterolsTriglyceridescholesterolflow-mediated dilationplant sterolsrandomized controlled trialvascular function

Identifiers

PMID25809853
PMCPMC4381780

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.