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Gene Influence in the Effectiveness of Plant Sterols Treatment in Children: Pilot Interventional Study.

ABSTRACT: Cardiovascular disease is linked to high serum low density lipoprotein (LDL)-cholesterol levels. Cardiovascular risk may be indirectly influenced by genetic load. Serum LDL-cholesterol levels may be reduced by the consumption of food enriched with plant sterols (PS). The aim was to test a plant sterol treatment on cholesterol levels according to different genetic polymorphisms. A pilot interventional trial was performed in 26 children (n = 16 girls, n = 10 boys). Seven hundred milliliters/day of commercial skimmed milk with added plant sterols delivering 2.2 g plant sterols were ingested for three weeks. Blood draws were performed at the baseline and end of the study. Significant modifications of non-high density lipoprotein (HDL)-cholesterol (p = 0.010; p = 0.013) and LDL-cholesterol (p = 0.004; p = 0.013) levels appeared in the genes LIPC C-514T and PPAR-? L162V carriers. No statistically significant differences were observed for other genes. LIPC C-514T and PPAR-alpha L162V carriers could benefit from a plant sterol supplement to ameliorate hypercholesterolemia.

SUBMITTER: San Mauro Martin I

PROVIDER: S-EPMC6835666 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Gene Influence in the Effectiveness of Plant Sterols Treatment in Children: Pilot Interventional Study.

San Mauro Martín Ismael I Garicano Vilar Elena E Sanz Rojo Sara S Collado Yurrita Luis L Pérez Arruche Eva E Arce Delgado Esperanza E Blumenfeld Olivares Javier Andrés JA

Nutrients 20191021 10

Cardiovascular disease is linked to high serum low density lipoprotein (LDL)-cholesterol levels. Cardiovascular risk may be indirectly influenced by genetic load. Serum LDL-cholesterol levels may be reduced by the consumption of food enriched with plant sterols (PS). The aim was to test a plant sterol treatment on cholesterol levels according to different genetic polymorphisms. A pilot interventional trial was performed in 26 children (<i>n</i> = 16 girls, <i>n</i> = 10 boys). Seven hundred mill ...[more]

PMID: 31640222

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Project description:IntroductionTinnitus may have a very severe impact on the quality of life. Unfortunately, for many patients, a satisfactory treatment modality is lacking. The auditory brainstem implant (ABI) was originally indicated for hearing restoration in patients with non-functional cochlear nerves, for example, in neurofibromatosis type II. In analogy to a cochlear implant (CI), it has been demonstrated that an ABI may reduce tinnitus as a beneficial side effect. For tinnitus treatment, an ABI may have an advantage over a CI, as cochlear implantation can harm inner ear structures due to its invasiveness, while an ABI is presumed to not damage anatomical structures. This is the first study to implant an ABI to investigate its effect on intractable tinnitus.Methods and analysisIn this pilot study, 10 adults having incapacitating unilateral intractable tinnitus and ipsilateral severe hearing loss will have an ABI implanted. The ABI is switched on 6 weeks after implantation, followed by several fitting sessions aimed at finding an optimal stimulation strategy. The primary outcome will be the change in Tinnitus Functioning Index. Secondary outcomes will be tinnitus burden and quality of life (using Tinnitus Handicap Inventory and Hospital Anxiety and Depression Scale questionnaires), tinnitus characteristics (using Visual Analogue Scale, a tinnitus analysis), safety, audiometric and vestibular function. The end point is set at 1 year after implantation. Follow-up will continue until 5 years after implantation.Ethics and disseminationThe protocol was reviewed and approved by the Institutional Review Board of the University Medical Centre Groningen, The Netherlands (METc 2015/479). The trial is registered at www.clinicialtrials.gov and will be updated if amendments are made. Results of this study will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberNCT02630589.Trial statusInclusion of first patient in November 2017. Data collection is in progress. Trial is open for further inclusion. The trial ends at 5 years after inclusion of the last patient.

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Project description: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.

Dataset Information

Gene Influence in the Effectiveness of Plant Sterols Treatment in Children: Pilot Interventional Study.

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Gene Influence in the Effectiveness of Plant Sterols Treatment in Children: Pilot Interventional Study.

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