Double-Blind Randomized Placebo Controlled Trial Demonstrating Serum Cholesterol Lowering Efficacy of a Smoothie Drink with Added Plant Stanol Esters in an Indonesian Population

Lanny Lestiani, Dian Novita Chandra, Kirsi Laitinen, Fransisca Diah Ambarwati, Päivi Kuusisto, Widjaja Lukito, Lanny Lestiani, Dian Novita Chandra, Kirsi Laitinen, Fransisca Diah Ambarwati, Päivi Kuusisto, Widjaja Lukito

Abstract

Indonesians have a high intake of saturated fats, a key contributing dietary factor to elevated blood cholesterol concentrations. We investigated the cholesterol lowering efficacy of a smoothie drink with 2 grams of plant stanols as esters to lower serum total and LDL-cholesterol concentrations in hypercholesterolemic Indonesian adults. The double-blind randomized placebo controlled parallel design study involved 99 subjects. Fifty subjects received control drink and dietary advice, and 49 subjects received intervention drink (Nutrive Benecol®) and dietary advice. Baseline, midline (week 2), and endline (week 4) assessments were undertaken for clinical, anthropometric, and biochemical variables. Compared to control, the smoothie drink with plant stanols reduced serum LDL-cholesterol concentration by 7.6% (p < 0.05) and 9.0% (p < 0.05) in two and four weeks, respectively. Serum total cholesterol was reduced by 5.7% (p < 0.05 compared to control) in two weeks, and no further reduction was detected after four weeks (5.6%). Compared to baseline habitual diet, LDL-cholesterol was reduced by 9.3% (p < 0.05) and 9.8% (p < 0.05) in the plant stanol ester group in two and four weeks, respectively. We conclude that consumption of smoothie drink with added plant stanol esters effectively reduces serum total and LDL-cholesterol of hypercholesterolemic Indonesian subjects already in two weeks. Trial is registered as NCT02316808.

Figures

Figure 1
Figure 1
Study flow chart. BMI, body mass index; TC, total cholesterol; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol.

References

    1. Hussain M. A., Mamun A. A., Peters S. A. E., Woodward M., Huxley R. R. The burden of cardiovascular disease attributable to major modifiable risk factors in Indonesia. Journal of Epidemiology. 2016;26(10):515–521. doi: 10.2188/jea.JE20150178.
    1. Prevention and Control of Non-Communicable Diseases. Jakarta, Republic of Indonesia: Center for Health Promotion, Ministry of Health; 2003.
    1. World Health Organization, Noncommunicable Diseases (NCD) Country Profiles, 2014,
    1. Expert Panel on Dyslipidemia. An International Atherosclerosis Society position paper, Global recommendations for the management of dyslipidemia: Executive summary, Expert Panel on Dyslipidemia. Atherosclerosis. 2014;232:410–413.
    1. Davies M. J., Woolf N. Atherosclerosis: what is it and why does it occur? Heart. 1993;69(1 Suppl):S3–S11. doi: 10.1136/hrt.69.1_Suppl.S3.
    1. National Cholesterol Education Program (NCEP) Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(19):3143–3421.
    1. Lichtenstein A. H., Appel L. J., Brands M., et al. Diet and lifestyle recommendations revision 2006: a scientific statement from the American heart association nutrition committee. Circulation. 2006;114(1):82–96. doi: 10.1161/CIRCULATIONAHA.106.176158.
    1. Gylling H., Plat J., Turley S., et al. Plant sterols and plant stanols in the management of dyslipidaemia and prevention of cardiovascular disease. Atherosclerosis. 2014;232(2):346–360. doi: 10.1016/j.atherosclerosis.2013.11.043.
    1. Musa-Veloso K., Poon T. H., Elliot J. A., Chung C. A comparison of the LDL-cholesterol lowering efficacy of plant stanols and plant sterols over a continuous dose range: results of a meta-analysis of randomized, placebo-controlled trials. Prostaglandins, Leukotrienes and Essential Fatty Acids. 2011;85(1):9–28. doi: 10.1016/j.plefa.2011.02.001.
    1. Harika R. K., Eilander A., Alssema M., Osendarp S. J. M., Zock P. L. Intake of fatty acids in general populations worldwide does not meet dietary recommendations to prevent coronary heart disease: A systematic review of data from 40 countries. Annals of Nutrition and Metabolism. 2013;63(3):229–238. doi: 10.1159/000355437.
    1. Micha R., Khatibzadeh S., Shi P., et al. Global, regional, and national consumption levels of dietary fats and oils in 1990 and 2010: A systematic analysis including 266 country-specific nutrition surveys. British Medical Journal. 2014;348 doi: 10.1136/bmj.g2272.g2272
    1. Djuwita-Hatma R. Nutrient intake patterns and their relations to lipid profiles in diverse ethnic populations [phd thesis] Jakarta, Indonesia: Postgraduate Program in Nutrition, Faculty of Medicine, Jakarta, Universitas Indonesia; 2001.
    1. Friedewald W. T., Levy R. I., Fredrickson D. S. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clinical Chemistry. 1972;18(6):499–502.
    1. Kalim H., Karo-Karo S., Setianto B., et al. Indonesian Nutritional Guidelines for Cardiovascular Health. Jakarta, Indonesia: Indonesian Heart Association and Indonesian Heart Foundation; 2002.
    1. Vanhanen H. T., Kajander J., Lehtovirta H., Miettinen T. A. Serum levels, absorption efficiency, faecal elimination and synthesis of cholesterol during increasing doses of dietary sitostanol esters in hypercholesterolaemic subjects. Clinical Science. 1994;87(1):61–67. doi: 10.1042/cs0870061.
    1. Miettinen T. A., Puska P., Gylling H., Vanhanen H., Vartiainen E. Reduction of serum-cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population. The New England Journal of Medicine. 1995;333(20):1308–1312. doi: 10.1056/nejm199511163332002.
    1. Andersson A., Karlström B., Mohsen R., Vessby B. Cholesterol-lowering effects of a stanol ester-containing low-fat margarine used in conjunction with a strict lipid-lowering diet. European Heart Journal Supplements. 1999;1:S80–S90.
    1. Hallikainen M. A., Uusitupa M. I. J. Effects of 2 low-fat stanol ester-containing margarines on serum cholesterol concentrations as part of a low-fat diet in hypercholesterolemic subjects. American Journal of Clinical Nutrition. 1999;69(3):403–410.
    1. Plat J., Brufau G., Dallinga-Thie G. M., Dasselaar M., Mensink R. P. A plant stanol yogurt drink alone or combined with a low-dose statin lowers serum triacylglycerol and non-HDL cholesterol in metabolic syndrome patients. Journal of Nutrition. 2009;139(6):1143–1149. doi: 10.3945/jn.108.103481.
    1. Mensink R. P., Ebbing S., Lindhout M., Plat J., van Heugten M. M. A. Effects of plant stanol esters supplied in low-fat yoghurt on serum lipids and lipoproteins, non-cholesterol sterols and fat soluble antioxidant concentrations. Atherosclerosis. 2002;160(1):205–213. doi: 10.1016/s0021-9150(01)00562-7.
    1. Hallikainen M., Olsson J., Gylling H. Low-fat nondairy minidrink containing plant stanol ester effectively reduces LDL cholesterol in subjects with mild to moderate hypercholesterolemia as part of a western diet. Cholesterol. 2013;2013:8. doi: 10.1155/2013/192325.192325
    1. Vasquez-Trespalacios E. M., Romero-Palacio J. Efficacy of yogurt drink with added plant stanol esters (Benecol®, Colanta) in reducing total and LDL cholesterol in subjects with moderate hypercholesterolemia: a randomized placebo-controlled crossover trial NCT01461798. Lipids in Health and Disease. 2014;13, article 125 doi: 10.1186/1476-511x-13-125.
    1. Párraga-Martínez I., López-Torres-Hidalgo J. D., Del Campo-Del Campo J. M., et al. Long-term effects of plant stanols on the lipid profile of patients with hypercholesterolemia. A randomized clinical trial. Revista Española de Cardiología. 2015;68(8):665–671. doi: 10.1016/j.recesp.2014.07.036.
    1. Kriengsinyos W., Sumriddetchkajorn K., Yamborisut U. Reduction of LDL-cholesterol in mildly hypercholesterolemic Thais with plant stanol ester fortified soy milk. Journal of the Medical Association of Thailand. 2011;94(11):1327–1336.
    1. Kriengsinyos W., Wangtong A., Komindr S. Serum cholesterol reduction efficacy of biscuits with added plant stanol ester. Cholesterol. 2015;2015:9. doi: 10.1155/2015/353164.353164
    1. Chaiyodsilp S., Chaiyodsilp P., Pureekul T., Srisawas R., Khunaphakdipong Y. A prospective randomized trial for reduction on serum low density lipoprotein (LDL) with plant stanol ester mixed in coffee in a hypercholesterolemic Thai population. The Bangkok Medical Journal. 2013;5:9–12.
    1. Hyun Y. J., Kim O. Y., Kang J. B., et al. Plant stanol esters in low-fat yogurt reduces total and low-density lipoprotein cholesterol and low-density lipoprotein oxidation in normocholesterolemic and mildly hypercholesterolemic subjects. Nutrition Research. 2005;25:743–53.
    1. Homma Y., Ikeda I., Ishikawa T., Tateno M., Sugano M., Nakamura H. Decrease in plasma low-density lipoprotein cholesterol, apolipoprotein B, cholesteryl ester transfer protein, and oxidized low-density lipoprotein by plant stanol ester-containing spread: a randomized, placebo-controlled trial. Nutrition Journal . 2003;19(4):369–374. doi: 10.1016/s0899-9007(02)00926-7.
    1. Ngwenya E., Ray R. Changes in Indonesian Food Consumption Patterns and their Nutritional Implications”, Discussion Paper, School of Economics and Finance, Hobart, 2007.
    1. Hatma R. D., Lukito W., Rumawas Y. S. P. Fatty acids intake among diverse ethnic groups in Indonesia. Medical Journal of Indonesia. 2005;14(4):242–248. doi: 10.13181/mji.v14i4.203.
    1. FAOSTAT Country profiles, Indonesia. Food and Agriculture Organization of the United Nations. Available in .
    1. Musa-Veloso K., Poon T. H. Rebuttal to comment from Demonty et al. Prostaglandins, Leukotrienes and Essential Fatty Acids. 2011;85(3-4):189–193. doi: 10.1016/j.plefa.2011.07.003.
    1. Ras R. T., Geleijnse J. M., Trautwein E. A. LDL-cholesterol-lowering effect of plant sterols and stanols across different dose ranges: a meta-analysis of randomised controlled studies. British Journal of Nutrition. 2014;112(2):214–219. doi: 10.1017/s0007114514000750.
    1. Athyros V. G., Kakafika A. I., Papageorgiou A. A., et al. Effect of a plant stanol ester-containing spread, placebo spread, or mediterranean diet on estimated cardiovascular risk and lipid, inflammatory and haemostatic factors. Nutrition, Metabolism & Cardiovascular Diseases. 2011;21(3):213–221. doi: 10.1016/j.numecd.2009.08.014.
    1. Laitinen K., Gylling H. Dose-dependent LDL-cholesterol lowering effect by plant stanol ester consumption: Clinical evidence. Lipids in Health and Disease. 2012;11, article no. 140 doi: 10.1186/1476-511X-11-140.
    1. EFSA Panel on Dietetic Products. Scientific Opinion on the substantiation of a health claim related to 3 g/day plant stanols as plant stanol esters and lowering blood LDL-cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal. 2012;10(5):p. 2692. doi: 10.2903/j.efsa.2012.2692.
    1. Gylling H., Hallikainen M., Nissinen M. J., Miettinen T. A. The effect of a very high daily plant stanol ester intake on serum lipids, carotenoids, and fat-soluble vitamins. Clinical Nutrition. 2010;29(1):112–118. doi: 10.1016/j.clnu.2009.08.005.
    1. Demonty I., Ras R. T., Van Der Knaap H. C. M., et al. Continuous dose-response relationship of the LDL-cholesterol-lowering effect of phytosterol intake. Journal of Nutrition. 2009;139(2):271–284. doi: 10.3945/jn.108.095125.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する