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Effects of Low-Fat Stanol Ester Enriched Margarines on Concentrations of Serum Carotenoids in Subjects with Elevated Serum Cholesterol Concentrations

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Effects of Low-Fat Stanol Ester Enriched Margarines on Concentrations of Serum Carotenoids in Subjects with Elevated Serum Cholesterol Concentrations European Journal of Clinical Nutrition (1999) 53, 966±969 ß 1999 Stockton Press. All rights reserved 0954±3007/99 $15.00 http://www.stockton-press.co.uk/ejcn Effects of low-fat stanol ester enriched margarines on concentrations of serum carotenoids in subjects with elevated serum cholesterol concentrations MA Hallikainen1*, ES Sarkkinen1 and MIJ Uusitupa1 1Department of Clinical Nutrition, University of Kuopio, Kuopio, Finland Objective: To investigate the effects of low-fat stanol ester margarines on concentrations of serum carotenoids. Design: A randomized parallel double-blind study design consisting of a 4-week run-in (high-fat diet) and an 8- week experimental (low-fat, low-cholesterol diet) period. During the experimental diet period subjects consumed low-fat wood stanol ester (WSEM), vegetable oil stanol ester (VOSEM) or control (no stanol esters) margarine daily. The daily mean total stanol intake was 2.31 and 2.16 g in the WSEM and VOSEM groups, respectively. Setting: Outpatient clinical trial with free-living subjects. Subjects: Altogether, 60 hypercholesterolaemic subjects were selected for the study out of 91 originally screened. The study was completed by 55 subjects. Main outcomes measures: Serum a- and b-carotene and lycopene determined by the HPLC. Results: Serum a-carotene concentration did not change signi®cantly in either of the experimental groups, whereas b-carotene concentration decreased signi®cantly in the WSEM and VOSEM groups (P < 0.01), and the change differed signi®cantly (P < 0.05 and P < 0.01, respectively) from that of the control group. Decrease in a+b-carotene concentration was signi®cantly greater (P < 0.05) in both experimental groups than in the control group. However, the change in a-, b-ora+b-carotene=total cholesterol ratio did not differ signi®cantly among the groups. No signi®cant changes were found in serum lycopene or lycopene=total cholesterol ratio in both experimental groups. Conclusions: Low-fat stanol ester margarines appeared to have little effect on serum concentrations of a-, b-ora + b-carotene, or lycopene. Sponsorship: Grant to the University of Kuopio by Raisio Benecol Ltd, Raisio, Finland. Descriptors: plant sterols; carotenoid; lycopene; a-carotene; b-carotene; cholesterol Introduction studied carotenoid in this respect is b-carotene (Gerster 1993; Mayne, l996). Plant sterols have been found to reduce serum cholesterol Lycopene is one of the most abundant carotenoids in concentrations by inhibiting the absorption of both dietary human blood and tissues; it has not been found to have a and biliary cholesterol from the small intestine (Heinemann provitamin A activity, but it has been found to have et al, 1991; Becker et al, 1993; Gylling et al, 1997). They antioxidant properties (Clinton, 1998). Therefore, we inves- may also reduce the concentrations of serum carotenoids, tigated the effects of two low-fat margarines enriched with particularly serum b-carotene concentration (Gylling et al, wood- or vegetable oil-based plant stanol esters on serum 1996). In a recently published study it was observed that lycopene and a- and a + b-carotene concentrations as part plant sterol-enriched margarines reduced plasma lycopene of a low-fat diet. Results on serum lipids have been as well as a+b-carotene concentrations, even if the changes published elsewhere (Hallikainen & Uusitupa,1999). in plasma lipid concentrations were taken into account (Weststrate & Meijer, 1998). Reduction in serum carote- noid concentrations can be undesirable, because there are Methods indications that carotenoids could have bene®cial effects on Subjects, study design, diets and laboratory measurements human health (Gerster 1993; Mayne, 1996). The most have been described in more detail elsewhere (Hallikainen & Uusitupa, 1999). *Correspondence: M Hallikainen, Department of Clinical Nutrition, University of Kuopio, PO Box 1627, FIN-70211 Kuopio, Finland. Subjects E-mail Maarit.Hallikainen@uku.®. Altogether 60 hypercholesterolaemic subjects were Contributors: MIJU was responsible for study design. MAH recruited the selected for the study out of 9l originally screened subjects. subjects, gave nutrition counsel, analysed and interpreted the data and The study was completed by 55 subjects, whose baseline wrote the manuscript. MIJU and ESS contributed to planning the diets, interpreting the data and writing the manuscript. characteristics are shown in Table 1. The study protocol Guarantor: M Uusitupa was approved by the Ethics Committee of the University of Received 18 March, 1999; revised 14 June 1999; accepted 30 June 1999 Kuopio and all subjects gave their written consent. Elevated serum cholesterol concentrations MA Hallikainen et al 967 Table 1 Baseline characteristics of the subjects, intake of plant stanols and serum carotenoid concentrations during the studya WSEM (N=18) VOSEM (N=20)b CONTROL (N=17) P-valuesc Men=women 8=10 6=14 6=11 Age (y) 43.2Æ 8.2 40.8Æ 9.3 46.0Æ 8.2 NS Body mass index (kg=m2) 25.6Æ 4.0 24.2Æ 3.0 25.7Æ 3.5 NS Intake of plant stanols from test margarines 2.31Æ 0.03 2.16Æ 0.12 0 (g=d) Sitostanol 2.13Æ 0.03 1.47Æ 0.08 0 Campestanol 0.19Æ 0.0 0.69Æ 0.04 0 Serum concentrations of carotenoids a-carotene (mmol=l): At 0 weeks 0.33Æ 0.23 0.33Æ 0.20 0.35Æ 0.39 NS At 8 weeks 0.31Æ 0.19 0.29Æ 0.11 0.28Æ 0.10 NS Changes (from 0 to 8 weeks) 0.02Æ 0.16 0.04Æ 0.13 0.07Æ 0.40 NS P-valuesd NS NS NS b-carotene (mmol=l): At 0 weeks 1.66Æ 1.10 1.47Æ 0.79 1.00Æ 0.37 0.063 At 8 weeks 1.22Æ 0.97 1.07Æ 0.54 1.06Æ 0.42 NS Changes (from 0 to 8 weeks) e 0.44Æ 0.57* 0.40Æ 0.54{ 0.05Æ 0.26 0.002 P-valuesd 0.002 0.001 NS a+b-carotene (mmol=l): At 0 weeks 2.00Æ 1.24 1.80Æ 0.91 1.35Æ 0.49 NS At 8 weeks 1.53Æ 1.11 1.36Æ 0.61 1.34Æ 0.46 NS Changes (from 0 to 8 weeks) 0.47Æ 0.65* 0.44Æ 0.59* 0.02Æ 0.53 0.004 P-valuesd 0.010 0.010 NS Lycopene (mmol=l): At 0 weeks 0.96Æ 0.67 1.04Æ 0.92 0.58Æ 0.42 0.072 At 8 weeks 0.97Æ 0.54 0.98Æ 0.57 0.77Æ 0.37 NS Changes (from 0 to 8 weeks)e 0.01Æ 0.82 ±0.06Æ 0.84 0.19Æ 0.38 NS P-valuesd NS NS NS a-carotene=total cholesterol ratio: At 0 weeks 0.05Æ 0.04 0.06Æ 0.04 0.06Æ 0.07 NS At 8 weeks 0.06Æ 0.04 0.06Æ 0.03 0.05Æ 0.02 NS Changes (from 0 to 8 weeks) 0.01Æ 0.03 0.00Æ 0.02 ±0.01Æ 0.07 NS P-valuesd NS NS 0.018 b-carotene=total cholesterol ratio: At 0 weeks 0.27Æ 0.21 0.24Æ 0.13 0.17Æ 0.07 NS At 8 weeks 0.24Æ 0.23 0.21Æ 0.10 0.19Æ 0.08 NS Changes (from 0 to 8 weeks) 0.03Æ 0.12 0.03Æ 0.08 0.02Æ 0.05 NS P-valuesd NS NS NS a+b-carotene=total cholesterol ratio: At 0 weeks 0.32Æ 0.24 0.30Æ 0.16 0.23Æ 0.09 NS At 8 weeks 0.30Æ 0.26 0.27Æ 0.12 0.24Æ 0.09 NS Changes (from 0 to 8 weeks) 0.02Æ 0.14 0.03Æ 0.09 0.01Æ 0.10 NS P-valuesd NS NS NS Lycopene=total cholesterol ratio: At 0 weeks 0.15Æ 0.11 0.18Æ 0.18 0.10Æ 0.06 NS At 8 weeks 0.18Æ 0.11 0.20Æ 0.12 0.14Æ 0.08 NS Changes (from 0 to 8 weeks) 0.04Æ 0.16 0.02Æ 0.14 0.05Æ 0.07 NS P-valuesd NS NS 0.010 aValues are meansÆ s.d. bN 19 for results concerning lycopene and lycopene=total cholesterol ratio. cIndicates the signi®cance of the difference among the groups analysed with a single measurement simple factorial analysis of variance (ANOVA) test (age, body mass index, b-carotene, lycopene and ratios of b-carotene=total cholesterol and lycopene=total cholesterol) or the Kruskal±Wallis one way ANOVA test (a-carotene, a b-carotene and ratios of a- carotene=total cholesterol and a+b-carotene=total cholesterol). dIndicates the signi®cance of the difference within the group during the experimental period analysed with a paired t-test or the Wilcoxon matched paired signed rank test. eThe initial concentrations were almost signi®cantly different among the study groups analysed with ANOVA, and therefore the initial concentrations have been taken into account in the between groups comparisons by dividing the response variable by the initial value *P < 0.05, {P < 0.01 indicate the signi®cances of the differences between the experimental study groups and the control group analysed with Student's t-test or the Mann±Whitney U-test with Bonferroni correction. Study design next 8 weeks. As part of that diet the subjects consumed The study has carried out with a parallel double-blind study 25 g rapeseed oil-based low-fat margarine (Raisio Group design. All subjects started the study with a 4-week run-in Plc, Raisio, Finland) daily. The daily dose of the test (high-fat diet) period. At the end of the run-in period the margarines was taken in two to three portions in connection subjects were randomized into one of the three experimen- with the meals.
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