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Recommendations Summary

DLM: Plant Stanols and Sterols 2011

Click here to see the explanation of recommendation ratings (Strong, Fair, Weak, Consensus, Insufficient Evidence) and labels (Imperative or Conditional). To see more detail on the evidence from which the following recommendations were drawn, use the hyperlinks in the Supporting Evidence Section below.


  • Recommendation(s)

    DLM: Plant Stanols and Sterols

    If consistent with patient preference and not contraindicated by risks or harms,  the Registered Dietitian (RD) should consider incorporating plant sterol and stanol ester-enriched foods into a cardioprotective diet, to be consumed two or three times per day, for a total consumption of two to three grams per day. These doses further lower total cholesterol (TC) by 4% to 11% and low-density lipoprotein cholesterol (LDL-C) by 7% to 15%. Doses beyond three grams do not provide additional benefit. To prevent weight gain, isocalorically substitute stanol- and sterol-enriched foods for other foods. Plant stanols and plant sterols are also effective in people taking statin drugs.

    Rating: Strong
    Conditional

    DLM: Plant Stanols and Sterols and Adverse Effects

    The Registered Dietitian (RD) should be aware that research to date has not documented adverse effects,  including reduced absorption of carotenoids, retinol and tocopherols. Plant stanols and sterols may be included in a patient's nutrition prescription (e.g., two or three grams per day) to lower cholesterol.

    Research from 17 randomized controlled trials (RCTs) indicates effective serum cholesterol-lowering benefits without any reported adverse effects, including no significant effect on plasma fat soluble vitamin status. Two observational studies reported an association between plasma levels and aortic tissue concentration of stanols and sterols in a small number of individuals who consumed foods supplemented with plant sterol and stanol esters. The clinical significance of the association has not been documented.

    Rating: Fair
    Imperative

    • Risks/Harms of Implementing This Recommendation

      • Plant sterol and stanol products should not be used in individuals with the rare genetic disorder of sitosterolemia (Patel, 2008)
      • Spreads and other food sources of plant sterols and stanols can contain considerable calories. Caloric content should be considered while recommending appropriate weight control/loss strategies.
      • Cost considerations should be discussed with patients to enable them to make appropriate substitutions within their food budget
      • For more information, see Evaluating Safety: Data to Determine Risk.

    • Conditions of Application

      • Patient preference and acceptability.
      • Label advisory on product use.

    • Potential Costs Associated with Application

      There will be an increased cost for fortified food sources of plant stanols and sterols.

    • Recommendation Narrative

      Plant Stanols and Sterols

      A total of twenty studies provide evidence for the following:

      • Five positive quality randomized controlled trials (RCTs) of normocholesterolemic individuals (Hendricks et al, 2003; Quilez et al, 2003; Homma et al, 2003; Ntanios et al, 2002; Davidson et al, 2001) and seven positive quality RCTs (Christiansen et al, 2001; Miettinen et al, 1995, Devaraj et al, 2004; Tikkanen et al,  2001; Nestel et al, 2001; Hallikainen et al, 2000; Vanstone et al, 2002) of hypercholesterolemic individuals found sterol and stanol ester-enriched products lowered TC and LDL-C. Both sterols and stanols and the esterified and nonesterified forms were effective.
      • Many studies provided sterols or stanols in foods other than margarines, such as low-fat yogurt, bakery products, and salad dressings, and beneficial effects still persisted
      • Beneficial effects were seen when phytosterols were given as part of a low-fat, low cholesterol diet in three positive quality RCTs (Maki et al, 2001; Noakes et al, 2002; Volpe et al, 2001)
      • One study (Hallikainen et al, 2000) gave varying doses of plant stanols and found a dose response at lower levels, but increasing the dose from 2.4g to 3.2g per day did not provide further benefit
      • Two positive quality RCTs (Gylling et al, 1997; Blair et al, 2000) found that plant stanols are effective even when given with statin drugs
      • Studies included 16 positive quality RCTs (Blair et al, 2000; Christiansen et al, 2001; Devaraj et al, 2004; Gylling et al, 1997; Hendriks et al, 2003; Homma et al, 2003; Maki et al, 2001; Mensink et al, 2002; Miettinen et al, 1995; Nestel et al, 2001; Noakes et al, 2002; Ntanios et al, 2002; Quilez et al, 2003; Tikkanen et al, 2001; Vanstone et al, 2002; Volpe et al, 2001), two neutral quality RCTs (Davidson et al, 2001; Hallikainen et al, 2000), one negative quality consensus statement (Lichtenstein et al, 2001), one neutral quality meta-analysis (Mensink et al, 2003).

      Adverse Effects of Plant Stanols and Sterols 

      • Twenty-eight studies provide evidence that consumption of plant stanols and sterols was not associated with adverse effects. Seventeen RCTs demonstrated effective serum cholesterol-lowering benefits without any reported adverse effects, including NS effect on fat soluble vitamin status (assessed by plasma levels). Very limited data suggest otherwise. Two other positive quality studies (Amundsen et al, 2004; Mensink et al, 2002reported lowering of carotenoid levels. Although two positive quality observational studies (Silbernagel et al, 2009, Weingärtner et al, 2008) report a possible association between plasma or tissue sterol levels and increased risk of coronary heart disease (CHD), the short-term RCTs do not indicate negative effects on vascular function.
      • Six positive quality RCTs (Colgan H et al, 2004; De Jong et al, 2008; Korpela et al, 2006; Noakes et al 2002; Quilez et al, 2003; Tuomilehto J et al, 2009) and one positive quality non-randomized follow-up study of an RCT (Amundsen et al, 2004) found consuming foods rich in hydrocarbon carotenoids,  a- or ß-carotenoids and a-, ß- or total tocopherol with phytosterols maintained plasma levels 
      • One RCT (Davidson et al,  2001) gave up to 9g per day for eight weeks and found no evidence of adverse effects. This was confirmed by three other studies (Christiansen et al, 2001, Gylling et al, 2009, Hendriks et al, 2003that gave lower does of plant sterols and stanols, but for longer periods of time.  
      • Studies included 19 RCTs (Christiansen et al, 2001; Colgan H et al, 2004; Davidson MH et al, 2001; De Jong et al, 2008; Gylling et al, 2009; Hendriks et al, 2003; Homma et al, 2003; Korpela et al, 2006; Maki et al, 2001; Mensink et al, 2002; Nestel et al, 2001; Noakes M, Clifton P et al, 2002; Ntanios et al, 2002; O'Neill et al, 2005; Quilez et al, 2003; Raitakari et al, 2008; Schiepers OJ et al, 2009; Tuomilehto J et al, 2009; Volpe et al, 2001), one non-randomized follow-up study of an RCT (Amundsen et al, 2004), three case-control studies (Helske et al, 2008; Rajaratnam et al, 2000; Windler et al, 2009), and five correlation studies (Fassbender et al, 2008; Lea et al, 2006; Silbernagel G et al, 2009; Weingärtner et al, 2008; Wilund et al, 2009) 

    • Recommendation Strength Rationale

      • Consistency of results among multiple positive quality RCTs
      • Although the ethnicity of study participants was not identified in all studies, few studies did report this information and studies included many populations such as Caucasians, blacks, Hispanics, and Asians; and men and women
      • A biological plausibility for mechanisms of action of plant stanol and sterol esters-containing foods exists
      • A dose-response relationship exists
      • Conclusions statements are as follows:
        • Grade I: 1) Stanol/Sterol Effects on Cholesterol-lowering as Part of Cholesterol-lowering Diet; Effects on TC and LDL; 2) Further Reduction in TC and LDL in Patients Taking Statins
        • Grade II: 1) Comparison of Sterols/Stanols in Terms of Cholesterol-lowering; 2) Safety of Plant Stanols/Sterols
        • Grade III: 1) Comparison of Esterified and Nonesterified Forms in Terms of Cholesterol-lowering Effect; 2) Consumption of Carotenoid-rich Foods With Plant Stanols/Sterols
          • Above conclusion statements are based on 16 positive quality RCTs, two neutral quality RCTs, one negative quality consensus statement, and one neutral quality meta-analysis 
        • Grade II: Adverse Effects of Plant Stanols and Sterols, based on 17 positive quality RCTs, one neutral quality RCT, one positive quality non-randomized follow-up study of an RCT,  two positive quality case-control studies, one neutral quality case-control study,  five positive quality correlation studies and one neutral quality correlation study
      • Area of uncertainty: To date, no clinical outcome studies have evaluated the effects of stanols and sterols on CHD events.

    • Minority Opinions

      None.