PMID- 29795368 OWN - NLM STAT- MEDLINE DCOM- 20190401 LR - 20190401 IS - 2044-4052 (Electronic) IS - 2044-4052 (Linking) VI - 8 IP - 1 DP - 2018 May 25 TI - 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. PG - 30 LID - 10.1038/s41387-018-0039-8 [doi] LID - 30 AB - BACKGROUND: Managing 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). METHODS: In 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). RESULTS: Hundred 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. CONCLUSIONS: In 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. FAU - Trautwein, Elke A AU - Trautwein EA AD - Unilever R&D, Vlaardingen, The Netherlands. elke.trautwein@unilever.com. FAU - Koppenol, Wieneke P AU - Koppenol WP AD - Unilever R&D, Vlaardingen, The Netherlands. FAU - de Jong, Arienne AU - de Jong A AD - Unilever R&D, Vlaardingen, The Netherlands. FAU - Hiemstra, Harry AU - Hiemstra H AD - Unilever R&D, Vlaardingen, The Netherlands. FAU - Vermeer, Mario A AU - Vermeer MA AD - Unilever R&D, Vlaardingen, The Netherlands. FAU - Noakes, Manny AU - Noakes M AD - Commonwealth Scientific and Industrial Research Organisation (CSIRO), Health and Biosecurity, Adelaide, Australia. FAU - Luscombe-Marsh, Natalie D AU - Luscombe-Marsh ND AD - Commonwealth Scientific and Industrial Research Organisation (CSIRO), Health and Biosecurity, Adelaide, Australia. LA - eng SI - ClinicalTrials.gov/NCT02288585 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20180525 PL - England TA - Nutr Diabetes JT - Nutrition & diabetes JID - 101566341 RN - 0 (Blood Glucose) RN - 0 (Cholesterol, LDL) RN - 0 (Insulin) RN - 0 (Phytosterols) RN - 0 (Triglycerides) SB - IM MH - Adult MH - Australia MH - Blood Glucose MH - Cholesterol, LDL/*blood MH - Diabetes Mellitus, Type 2/*blood MH - Double-Blind Method MH - Dyslipidemias/blood/*diet therapy MH - Female MH - Humans MH - Insulin/blood MH - Male MH - Middle Aged MH - Phytosterols MH - Risk Assessment MH - Treatment Outcome MH - Triglycerides/*blood PMC - PMC5968034 COIS- This study was funded by Unilever BCS R&D, Vlaardingen, the Netherlands. E.A.T., W.P.K., A.dJ. (at the time of study conduct), H.H. and M.A.V. are employed by Unilever R&D. Unilever markets food products with added plant sterols. M.N. and N.D.L-M. are employed by CSIRO and declare no conflict of interest. EDAT- 2018/05/26 06:00 MHDA- 2019/04/02 06:00 PMCR- 2018/05/25 CRDT- 2018/05/26 06:00 PHST- 2018/02/07 00:00 [received] PHST- 2018/04/05 00:00 [accepted] PHST- 2018/03/15 00:00 [revised] PHST- 2018/05/26 06:00 [entrez] PHST- 2018/05/26 06:00 [pubmed] PHST- 2019/04/02 06:00 [medline] PHST- 2018/05/25 00:00 [pmc-release] AID - 10.1038/s41387-018-0039-8 [pii] AID - 39 [pii] AID - 10.1038/s41387-018-0039-8 [doi] PST - epublish SO - Nutr Diabetes. 2018 May 25;8(1):30. doi: 10.1038/s41387-018-0039-8.