Evidence map›Paper›PMID 29795368›Full record

Trial reportNutrition & diabetes2018

Plant sterols lower LDL-cholesterol and triglycerides in dyslipidemic individuals with or at risk of developing type 2 diabetes; a randomized, double-blind, placebo-controlled study.

Elke A Trautwein, Wieneke P Koppenol, Arienne de Jong, Harry Hiemstra, Mario A Vermeer, Manny Noakes, Natalie D Luscombe-Marsh

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrition & diabetes, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02288585 (The Effect of a Low-fat Spread Enriched With Plant Sterol Esters on the Blood Lipid Profile of Subjects With Established Type 2 Diabetes Mellitus and Subjects at High Risk of Developing Type 2 Diabetes), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
6.2field-weighted citation impact, top 3% of its field
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.

NCT02288585 nacompletednot on this map

The Effect of a Low-fat Spread Enriched With Plant Sterol Esters on the Blood Lipid Profile of Subjects With Established Type 2 Diabetes Mellitus and Subjects at High Risk of Developing Type 2 Diabetes

TypeinterventionalSponsorUnilever R&DRan2014 to 2016Enrolled150ConditionsVascular Diseases, Hypercholesterolemia, Diabetes MellitusArmsPlant sterols, Placebo product
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 45 citations in OpenAlex.

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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

7 authors at 2 institutions in 2 countries.

Elke A TrautweinUnilever R&D, Vlaardingen, The Netherlands. elke.trautwein@unilever.com.
Wieneke P KoppenolUnilever R&D, Vlaardingen, The Netherlands.
Arienne de JongUnilever R&D, Vlaardingen, The Netherlands.
Harry HiemstraUnilever R&D, Vlaardingen, The Netherlands.
Mario A VermeerUnilever R&D, Vlaardingen, The Netherlands.
Manny NoakesCommonwealth Scientific and Industrial Research Organisation (CSIRO), Health and Biosecurity, Adelaide, Australia.
Natalie D Luscombe-MarshCommonwealth Scientific and Industrial Research Organisation (CSIRO), Health and Biosecurity, Adelaide, Australia.
Unilever (Netherlands) · NLCSIRO Health and Biosecurity · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundManaging cardiovascular disease (CVD) risk factors, e.g., dyslipidemia in type-2 diabetes mellitus (T2DM) is critically important as CVD is the most common cause of death in T2DM patients. This study aimed to investigate the effect of plant sterols (PS) on lowering both elevated low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG).

methodsIn a double-blind, randomized, placebo-controlled, parallel study, 161 individuals at increased risk of and with established T2DM, consumed low-fat spreads without or with added PS (2 g/d) for 6 weeks after a 2-week run-in period. Increased risk of developing T2DM was defined by the Australian T2DM Risk Assessment Tool (AUSDRISK). Fasting serum/plasma total cholesterol (TC), LDL-C, TG, high-density lipoprotein cholesterol (HDL-C), glucose and insulin were measured at baseline and after 6 weeks. Effects on acute and chronic postprandial blood lipids, glucose and insulin were measured over 4-h in 39 individuals with T2DM following a mixed meal challenge without and with added 2 g/d PS at week 6. The study was registered at clinicaltrials.gov (NCT02288585).

resultsHundred fifty-one individuals completed the study and 138 (57% men, 43% women; 44 with and 94 at risk of T2DM) were included in per protocol analysis. Baseline LDL-C and TG were 3.8 ± 1.0 and 2.5 ± 0.8 mmol/l, respectively. PS intake significantly lowered fasting LDL-C (-4.6%, 95%CI -1.2; -8.0; p = 0.009), TC (-4.2%, 95%CI -1.2; -7.1; p = 0.006) and TG (-8.3%, 95% -1.1, -15.0; p = 0.024) with no significant changes in HDL-C, glucose or insulin. Postprandial lipid (TG, TC, LDL-C, HDL-C, remnant cholesterol), glucose and insulin responses did not differ.

conclusionsIn individuals at risk of and with established T2DM and with elevated TG and LDL-C, 2 g/d of PS results in dual LDL-C plus TG lowering. Postprandial lipid or glycemic responses did not differ between PS and control treatment.

Indexed as

AdultAustraliaBlood GlucoseCholesterol, LDLDiabetes Mellitus, Type 2Double-Blind MethodDyslipidemiasFemaleHumansInsulinMaleMiddle AgedPhytosterolsRisk AssessmentTreatment OutcomeTriglyceridesBlood GlucoseCholesterol, LDLInsulinPhytosterolsTriglycerides

Identifiers

PMID29795368
PMCPMC5968034
OpenAlexW2805852605

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.